Malignant Digestive System NeoplasmSTOP-VTENCT07215624
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
An observational study of Malignant Digestive System Neoplasm and Malignant Female Reproductive System Neoplasm, run by Wake Forest University Health Sciences at 104 sites in 2 countries.
Trial summary
This study evaluates the use of extended venous thromboembolism prophylaxis (ePPx) following abdominopelvic cancer surgery within the NCI Community Oncology Research Program (NCORP) network, targeting surgeons and surgical advanced practice providers (APPs). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Genitourinary System Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 500 participants
- Where
- 104 sitesin 2 countries
- Study dates
- 15 Jan 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This multi-part study employs a mixed-methods design to evaluate the utilization of ePPx following abdominopelvic cancer surgery within the NCORP network. Part 1 involves a cross-sectional survey of at least 100 surgeons/APPs from at least 25 NCORP sites to evaluate practice patterns related to ePPx. Part 2 utilizes purposive sampling to conduct interviews with 11-25 surgeons/APPs from Part 1 to obtain granular detail about barriers and facilitators to guideline concordant utilization of ePPx. Part 3 will purposively sample 6 practices identified in Part 1 to evaluate the feasibility of EHR queries to assess ePPx utilization.
Who may be able to join
- SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:
- Any surgeon performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgeons do not need to be involved in research or have a Cancer Therapy Evaluation Program Identification (CTEP ID) to participate in this study
- SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:
- APPs providing postoperative care to patients operated by surgeons performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgical APPs do not need to be involved in research or have a CTEP ID to participate in this study
- SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:
- Must have completed the STOP-VTE Survey - Surgeon electronically (preferred) or on paper and have it transferred to Research Electronic Data Capture (REDCap) by the contact person(s)
Show all 10Show fewer
- SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:
- Must have completed the STOP-VTE Survey - APP electronically (preferred) or on paper and have it transferred to REDCap by the contact person(s)
- SITE ELIGIBILITY PART 1-SITE ENROLLMENT IN OPEN:
- Have at least one eligible surgeon or surgical APP who completed the STOP-VTE Survey - Surgeon/APP
Who cannot join
- N/A
Trial locations and contacts
104 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
104 sites in 2 countries
United States103 sites, 103 recruiting
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Bernard Tawfik
- Recruiting
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
618-463-5623
Jay W Carlson
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Rose A Juhasz
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
404-303-3355, ClinicalTrials@northside.com
Guilherme H Cantuaria
- Recruiting
Augusta University Medical Center
Augusta, Georgia, 30912
706-721-2388, ga_cares@augusta.edu
Sharad A Ghamande
- Recruiting
Kaiser Permanente Bellevue Medical Center
Bellevue, Washington, 53215
414-302-2304, ncorp@aurora.org
Eric Y Chen
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Margaret Nolan
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
800-996-2663, research@billingsclinic.org
John M Schallenkamp
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
734-712-3671, stephanie.couch@stjoeshealth.org
Rose Ann Juhasz
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
406-969-6060, mccinfo@mtcancer.org
John M Schallenkamp
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
218-786-3308, CancerTrials@EssentiaHealth.org
Margaret Nolan
- Recruiting
Cox Cancer Center Branson
Branson, Missouri, 65616
417-269-4520
Jay W Carlson
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
952-993-1517, mmcorc@healthpartners.com
Margaret B Nolan
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
319-365-4673
Richard L Deming
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
319-363-2690
Deborah W Wilbur
- Recruiting
Charleston Oncology North Charleston
Charleston, South Carolina, 29406
843-724-2466, Julia.Johnson@rsfh.com
Matthew F Hudson
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Rose A Juhasz
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
312-864-5204
Deimante M Tamkus
- Recruiting
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
800-782-8581 ext. 94457, oncology.clinical.trials@marshfieldresearch.org
Anthony J Jaslowski
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
406-969-6060, mccinfo@mtcancer.org
John M Schallenkamp
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
952-993-1517, mmcorc@healthpartners.com
Margaret Nolan
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
570-271-5251, cancerresearch@geisinger.edu
Neda Amini
- Recruiting
Dayton Veterans Affairs Medical Center
Dayton, Ohio, 45428
937-528-2900, clinical.trials@daytonncorp.org
Shahzad Siddique
- Recruiting
Blank Children's Hospital
Des Moines, Iowa, 50309
515-241-8912, samantha.mallory@unitypoint.org
Seema Harichand-Herdt
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
515-241-6727
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
515-358-6613, cancerresearch@mercydesmoines.org
Richard L Deming
- Recruiting
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
515-241-8704
Richard L Deming
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
218-786-3308, CancerTrials@EssentiaHealth.org
Bret EB Friday
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
218-786-3308, CancerTrials@EssentiaHealth.org
Bret EB Friday
- Recruiting
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
218-786-3308, CancerTrials@EssentiaHealth.org
Margaret Nolan
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
952-993-1517, mmcorc@healthpartners.com
Margaret B Nolan
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
206-215-2343, PCRC-NCORP@Swedish.org
Alison K Conlin
- Recruiting
Christiana Care - Union Hospital
Elkton, Maryland, 02192
410-443-1360, frank.crum@christianacare.org
Gregory A Masters
- Recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
218-786-3308, CancerTrials@EssentiaHealth.org
Bret EB Friday
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
eileen.georgi@holy-cross.com
Rose Ann Juhasz
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
800-378-9373
Jay W Carlson
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y Butler
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
920-433-8889, WI_research_admin@hshs.org
Anthony J Jaslowski
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
920-433-8889, wi_research_admin@hshs.org
Anthony J Jaslowski
- Recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
864-522-4317, Kim.Williams3@prismahealth.org
Matthew F Hudson
- Recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
808-586-2979
Christa Braun-Inglis
- Recruiting
Tripler Army Medical Center
Honolulu, Hawaii, 96859
808-433-6336
Karen J Shou
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
206-215-2343, PCRC-NCORP@Swedish.org
Alison K Conlin
- Recruiting
Mercy Hospital Joplin
Joplin, Missouri, 64804
417-556-3074, esmeralda.carrillo@mercy.net
Jay W Carlson
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
913-588-3671, KUCC_Navigation@kumc.edu
Luke Vail Selby
- Recruiting
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116
913-588-3671
Jay W Carlson
- Recruiting
Kingman Regional Medical Center
Kingman, Arizona, 86401
702-384-0013, research@sncrf.org
Edgardo Rivera
- Recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
517-364-3712, harsha.trivedi@umhsparrow.org
Rose Ann Juhasz
- Recruiting
Northside Hospital - Gwinnett
Lawrenceville, Georgia, 30046
404-303-3355, Clinical.trials@northside.com
Guilherme Henrique C Cantuaria
- Recruiting
Lewistown Hospital
Lewistown, Pennsylvania, 17044
717-242-7703, cancerresearch@geisinger.edu
Neda Amini
- Recruiting
CommonSpirit Saint Joseph Medical Center - East Lexington
Lexington, Kentucky, 40509
720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Liberty Hospital
Liberty, Missouri, 64068
913-588-1569
Jay W Carlson
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Rose A Juhasz
- Recruiting
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
952-993-1517, mmcorc@healthpartners.com
Margaret B Nolan
- Recruiting
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
952-993-1517, mmcorc@healthpartners.com
Margaret B Nolan
- Recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
414-302-2304, ncorp@aurora.org
Thomas J Saphner
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
952-993-1517, mmcorc@healthpartners.com
Margaret B Nolan
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
952-993-1517, mmcorc@healthpartners.com
Margaret B Nolan
- Recruiting
Health Partners Inc
Minneapolis, Minnesota, 55454
952-993-1517, mmcorc@healthpartners.com
Margaret Nolan
- Recruiting
New Ulm Medical Center
New Ulm, Minnesota, 56073
952-993-1517, mmcorc@healthpartners.com
Margaret Nolan
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
302-623-4450, lbarone@christianacare.org
Gregory A Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
302-623-4450, lbarone@christianacare.org
Gregory A Masters
- Recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
302-623-4450, lbarone@christianacare.org
Gregory A Masters
- Recruiting
Licking Memorial Hospital
Newark, Ohio, 43055
614-488-2745, Jeffh@columbusccop.org
Aruna C Gowda
- Recruiting
Kaiser Permanente-Oakland
Oakland, California, 94611
877-642-4691, Kpoct@kp.org
Natalya Greyz-Yusupov
- Recruiting
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
405-752-3402
Jay W Carlson
- Recruiting
Lake Regional Hospital
Osage Beach, Missouri, 65065
573-302-2768, clinicaltrials@lakeregional.com
Jay W Carlson
- Recruiting
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
913-588-3671, KUCC_Navigation@kumc.edu
Luke Vail Selby
- Recruiting
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
910-715-3500, jcwilliams@firsthealth.org
Michael J Sundborg
- Recruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Rose A Juhasz
- Recruiting
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102
207-396-8670, clinicalresearch@mainehealth.org
Leslie S Bradford
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
503-215-2614, CanRsrchStudies@providence.org
Alison K Conlin
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
503-215-2614, CanRsrchStudies@providence.org
Alison K Conlin
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
804-628-6430, CTOclinops@vcu.edu
Ricardo Julio Bello Boccardo
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
952-993-1517, mmcorc@healthpartners.com
Margaret N Nolan
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
952-993-1517, mmcorc@healthpartners.com
Margaret B Nolan
- Recruiting
United Hospital
Saint Paul, Minnesota, 55102
952-993-1517, mmcorc@healthpartners.com
Margaret Nolan
- Recruiting
Kaiser Permanente-San Francisco
San Francisco, California, 94115
877-642-4691, Kpoct@kp.org
Natalya Greyz-Yusupov
- Recruiting
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
877-642-4691, Kpoct@kp.org
Natalya Greyz-Yusupov
- Recruiting
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
207-396-8670, clinicalresearch@mainehealth.org
Leslie S Bradford
- Recruiting
Community Medical Center
Scranton, Pennsylvania, 18510
570-703-4768, cancerresearch@geisinger.edu
Neda Amini
- Recruiting
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
206-215-3086, PCRC-NCORP@Swedish.org
Alison K Conlin
- Recruiting
Kaiser Permanente Washington
Seattle, Washington, 98112
206-287-2049, KPWAoncologytrials@kp.org
Eric Y Chen
- Recruiting
Swedish Medical Center-First Hill
Seattle, Washington, 98122
206-215-2343, PCRC-NCORP@Swedish.org
Alison K Conlin
- Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org
Daniel Almquist
- Recruiting
Mercy Hospital Springfield
Springfield, Missouri, 65804
417-269-4520
Jay W Carlson
- Recruiting
CoxHealth South Hospital
Springfield, Missouri, 65807
417-269-4520
Jay W Carlson
- Recruiting
Mercy Hospital South
St Louis, Missouri, 63128
314-525-6042, Danielle.Werle@mercy.net
Jay W Carlson
- Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
314-251-7066
Jay W Carlson
- Recruiting
Lakeview Hospital
Stillwater, Minnesota, 55082
952-993-1517, mmcorc@healthpartners.com
Margaret Nolan
- Recruiting
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
718-379-6866, eskwak@montefiore.org
Matthew W Cowan
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
718-379-6866, eskwak@montefiore.org
Matthew W Cowan
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
800-446-5532, Research@carle.com
Megan L Hutchcraft
- Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
218-786-3308, CancerTrials@EssentiaHealth.org
Bret EB Friday
- Recruiting
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
877-642-4691, Kpoct@kp.org
Natalya Greyz-Yusupov
- Recruiting
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
877-405-6866
Anthony J Jaslowski
- Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
913-588-3671, KUCC_Navigation@kumc.edu
Luke Vail Selby
- Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
570-271-5251, HemonCCTrials@geisinger.edu
Neda Amini
- Recruiting
Wake Forest NCORP Research Base
Winston-Salem, North Carolina, 27157
Kathryn E Weaver, PhD, 336-716-0891, ncorp@wfusm.edu
Karen T Craver, MT,MHA, 336-716-0891, ncorp@wfusm.edu
- Recruiting
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
952-993-1517, mmcorc@healthpartners.com
Margaret B Nolan
Puerto Rico1 site, 1 recruiting
- Recruiting
San Patricio Medflix
Guaynabo, 00968
787-936-1477 ext. 5206, dcuadrado@cccupr.org
Luis J Santos Reyes
About this study
Official title: Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network (STOP-VTE)
This study evaluates the use of extended venous thromboembolism prophylaxis (ePPx) following abdominopelvic cancer surgery within the NCI Community Oncology Research Program (NCORP) network, targeting surgeons and surgical advanced practice providers (APPs).
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate self-reported utilization of guideline concordant extended venous thromboembolism (VTE) prophylaxis (ePPx) following abdominopelvic cancer surgery within a sample of surgeons practicing within NCORP based on the Part 1 surgeon survey.
SECONDARY OBJECTIVES:
- Evaluate site factors (e.g., proportion of publicly insured patients, proportion of Black patients, presence of a medical school, NCI designation) and surgeon factors (e.g., fellowship training, years in practice) associated with surgeon self-reported guideline concordant ePPx utilization (Part 1).
II. Conduct semi-structured interviews among a subset of surgeons and surgical APPs to assess: 1) Barriers/facilitators toward ePPx after cancer surgery and 2) Acceptability of clinical decision support tools to support VTE prophylaxis prescribing (Part 2).
III. Extract EHR data from select practices to assess the feasibility of query-based electronic health record (EHR) data extraction for identification of (i) patients undergoing cancer surgery, and (ii) prescription of guideline concordant ePPx among eligible patients (Part 3).
OUTLINE: This is an observational study.
PART 1: Surgeons and APPs complete a survey on study. After completion of surgeon or APP survey, site contact person or Cancer Care Delivery Research (CCDR) lead complete site surveys on study.
PART 2: A subset of surgeons and APPs from part 1 complete a semi-structured interview on study.
PART 3: Site contact person or CCDR lead complete a survey to identify a EHR Report Specialist on study. EHR Report Specialist performs an EHR Data Extraction and provides feedback on the process in a survey.
- Conditions
- Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Genitourinary System Neoplasm
- Being tested
- Non-Interventional Study
- Medical subject headings
- Gastrointestinal Neoplasms, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational Part 1 | Surgeons and APPs complete a survey on study. After completion of surgeon or APP survey, site contact person or CCDR lead complete site surveys on study. Receives: Other: Non-Interventional Study | |
| Observational Part 2 | Subset of surgeons and APPs from Part 1 complete a semi-structured interview on study. Receives: Other: Non-Interventional Study | |
| Observational Part 3 | Site contact person or CCDR lead complete a survey to identify a EHR Report Specialist on study. EHR Report Specialist performs an EHR Data Extraction and provides feedback on the process in a survey. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported utilization of guideline concordant ePPx for surgeons (Part 1)
Will apply only to surgeons completing the Part 1 survey. Will be defined as answering "Yes, all cases or almost all cases" on the survey question asking about prescription of ePPx after discharge. The proportion of surgeons self-reporting utilization of guideline concordant ePPx will be estimated and reported along with an exact 95% confidence interval.
Measured: After 1 year from start of Part 1
Secondary outcomes (3)
Self-reported utilization of guideline concordant ePPx for surgeons within strata defined by site and surgeon factors (Part 1)
Self reported utilization as defined above for the primary outcome measure will be reported within strata defined by:
- Site factors (e.g., proportion of publicly insured patients, proportion of Black patients, presence of a medical school, NCI designation)
- Surgeon factors (e.g., fellowship training, years in practice)
Measured: After 1 year from start of Part 1
Barriers and facilitators toward ePPx after cancer surgery, and acceptability of clinical decision support tools to support VTE prophylaxis prescribing (Part 2)
Themes from qualitative interviews by surgeons and APPs
Measured: After 6 months from start of Part 2
Feasibility (i.e., proportion of practices able to provide data) of EHR queries from selected practices to inform future trial (Part 3)
Considered feasible if at least 4 of the 6 practices who agreed to participate are able to provide data on both patients undergoing cancer surgery and prescription of guideline concordant ePPx among eligible patients
Measured: After 6 months from start of Part 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start15 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Digestive System NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Glenn Lesser, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215624
- Sponsor's protocol ID
- IRB00138219
- Other IDs
- NCI-2025-06376, WF-2502CD, WF-2502CD, WF-2502CD
- Acronym
- STOP-VTE
- Status last verified
- Nov 2026
- First submitted
- 29 Sep 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network (STOP-VTE)
- ClinicalTrials.gov ID
- NCT07215624
- Acronym / sponsor ID
- STOP-VTE / IRB00138219
- Conditions
- Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Genitourinary System Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the use of extended venous thromboembolism prophylaxis (ePPx) following abdominopelvic cancer surgery within the NCI Community Oncology Research Program (NCORP) network, targeting surgeons and surgical advanced practice providers (APPs).
Detailed description
PRIMARY OBJECTIVE:
- To evaluate self-reported utilization of guideline concordant extended venous thromboembolism (VTE) prophylaxis (ePPx) following abdominopelvic cancer surgery within a sample of surgeons practicing within NCORP based on the Part 1 surgeon survey.
SECONDARY OBJECTIVES:
- Evaluate site factors (e.g., proportion of publicly insured patients, proportion of Black patients, presence of a medical school, NCI designation) and surgeon factors (e.g., fellowship training, years in practice) associated with surgeon self-reported guideline concordant ePPx utilization (Part 1).
II. Conduct semi-structured interviews among a subset of surgeons and surgical APPs to assess: 1) Barriers/facilitators toward ePPx after cancer surgery and 2) Acceptability of clinical decision support tools to support VTE prophylaxis prescribing (Part 2).
III. Extract EHR data from select practices to assess the feasibility of query-based electronic health record (EHR) data extraction for identification of (i) patients undergoing cancer surgery, and (ii) prescription of guideline concordant ePPx among eligible patients (Part 3).
OUTLINE: This is an observational study.
PART 1: Surgeons and APPs complete a survey on study. After completion of surgeon or APP survey, site contact person or Cancer Care Delivery Research (CCDR) lead complete site surveys on study.
PART 2: A subset of surgeons and APPs from part 1 complete a semi-structured interview on study.
PART 3: Site contact person or CCDR lead complete a survey to identify a EHR Report Specialist on study. EHR Report Specialist performs an EHR Data Extraction and provides feedback on the process in a survey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational Part 1 | – | Other: Non-Interventional StudySurgeons and APPs complete a survey on study. After completion of surgeon or APP survey, site contact person or CCDR lead complete site surveys on study. |
| Observational Part 2 | – | Other: Non-Interventional StudySubset of surgeons and APPs from Part 1 complete a semi-structured interview on study. |
| Observational Part 3 | – | Other: Non-Interventional StudySite contact person or CCDR lead complete a survey to identify a EHR Report Specialist on study. EHR Report Specialist performs an EHR Data Extraction and provides feedback on the process in a survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This multi-part study employs a mixed-methods design to evaluate the utilization of ePPx following abdominopelvic cancer surgery within the NCORP network. Part 1 involves a cross-sectional survey of at least 100 surgeons/APPs from at least 25 NCORP sites to evaluate practice patterns related to ePPx. Part 2 utilizes purposive sampling to conduct interviews with 11-25 surgeons/APPs from Part 1 to obtain granular detail about barriers and facilitators to guideline concordant utilization of ePPx. Part 3 will purposively sample 6 practices identified in Part 1 to evaluate the feasibility of EHR queries to assess ePPx utilization.
Key inclusion criteria (10 listed)
- Any surgeon performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgeons do not need to be involved in research or have a Cancer Therapy Evaluation Program Identification (CTEP ID) to participate in this study
- APPs providing postoperative care to patients operated by surgeons performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgical APPs do not need to be involved in research or have a CTEP ID to participate in this study
- Must have completed the STOP-VTE Survey - Surgeon electronically (preferred) or on paper and have it transferred to Research Electronic Data Capture (REDCap) by the contact person(s)
- Must have completed the STOP-VTE Survey - APP electronically (preferred) or on paper and have it transferred to REDCap by the contact person(s)
- Have at least one eligible surgeon or surgical APP who completed the STOP-VTE Survey - Surgeon/APP
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational Part 1 |
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational Part 2 |
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational Part 3 |
Primary outcome
Self-reported utilization of guideline concordant ePPx for surgeons (Part 1)
Time frame: After 1 year from start of Part 1
Will apply only to surgeons completing the Part 1 survey. Will be defined as answering "Yes, all cases or almost all cases" on the survey question asking about prescription of ePPx after discharge. The proportion of surgeons self-reporting utilization of guideline concordant ePPx will be estimated and reported along with an exact 95% confidence interval.
3 secondary outcomes
Self-reported utilization of guideline concordant ePPx for surgeons within strata defined by site and surgeon factors (Part 1)
Time frame: After 1 year from start of Part 1
Barriers and facilitators toward ePPx after cancer surgery, and acceptability of clinical decision support tools to support VTE prophylaxis prescribing (Part 2)
Time frame: After 6 months from start of Part 2
Feasibility (i.e., proportion of practices able to provide data) of EHR queries from selected practices to inform future trial (Part 3)
Time frame: After 6 months from start of Part 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
Related trials for Malignant Digestive System Neoplasm
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 3
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Neoplasms
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn Lesser, MD study chair
Wake Forest University Health Sciences
104 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Digestive System Neoplasm and Malignant Female Reproductive System Neoplasm, run by Wake Forest University Health Sciences at 104 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Craver (336-716-0891, NCORP@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported utilization of guideline concordant ePPx for surgeons (Part 1) (time frame: After 1 year from start of Part 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.