Soft Tissue SarcomaNCT04553744
Identification of Surgical Management of Lymph Node Basins and Surgical Practice Patterns Among Sarcoma Surgeons
An observational study of Soft Tissue Sarcoma and Lymph Node Cancer, run by M.D. Anderson Cancer Center.
Trial summary
This study investigates the surgical management of lymph node basins for extremity and trunk soft tissue sarcoma (ETSTS) to identify and better understand the surgical practice patterns of sarcoma surgeons. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Sarcoma, Lymph Node Cancer
- What is being tested?
- Survey Administration
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2020to 26 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Practicing surgeons who are members of The Society of Surgical Oncology and Musculoskeletal Tumor Society, and treat extremity and trunk soft tissue sarcomas.
Who may be able to join
- Currently practicing surgeons who treat ETSTS and are members of The Society of Surgical Oncology and Musculoskeletal Tumor Society
Who cannot join
- None
About this study
Official title: Survey of Extremity and Trunk Sarcoma Surgeons Regarding Surgical Management of Lymph Node Basins
This study investigates the surgical management of lymph node basins for extremity and trunk soft tissue sarcoma (ETSTS) to identify and better understand the surgical practice patterns of sarcoma surgeons. ETSTS has been known to spread to distant locations including lymph nodes, with some subtypes of the disease spreading to lymph nodes more than others. This has led to sarcoma surgeons to treat patients differently from one another, including those with more lymph node involvement. The purpose of this study is to investigate the practice patterns of ETSTS surgeons.
Read the detailed description
PRIMARY OBJECTIVES:
- Identify the practice patterns of sarcoma surgeons with respect to management of lymph node basins for extremity and trunk soft tissue sarcomas (ETSTS).
II. Identify when surgeons would perform sentinel lymph node biopsy and/or lymph node dissection for ETSTS and if management differs for high-risk subtypes of sarcoma that are more likely to have nodal metastases.
III. Identify differences in practice patterns between surgical oncologists and orthopedic oncologic surgeons.
OUTLINE:
Participants complete an online survey over 5-10 minutes asking how they would manage lymph node basins in the extremity sarcoma.
- Conditions
- Soft Tissue Sarcoma, Lymph Node Cancer
- Being tested
- Survey Administration
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey) | Participants complete an online survey over 5-10 minutes asking how they would manage lymph node basins in the extremity sarcoma. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Practice patterns of sarcoma surgeons
Will identify the practice patterns of sarcoma surgeons with respect to management of lymph node basins for extremity and trunk soft tissue sarcomas (ETSTS).
Measured: Up to 2 years
Sentinel lymph node biopsy and/or lymph node dissection for ETSTS
Will identify when surgeons would perform sentinel lymph node biopsy and/or lymph node dissection for ETSTS, and if management differs for high-risk subtypes of sarcoma that are more likely to have nodal metastases.
Measured: Up to 2 years
Differences in practice patterns
Will identify differences in practice patterns between surgical oncologists and orthopedic oncologic surgeons.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start22 Jun 2020
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Why it stopped: 0 participant accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christina L Roland, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553744
- Sponsor's protocol ID
- 2020-0099
- Other IDs
- NCI-2020-06478, 2020-0099
- Status last verified
- Feb 2024
- First submitted
- 11 Sep 2020
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Extremity and Trunk Sarcoma Surgeons Regarding Surgical Management of Lymph Node Basins
- ClinicalTrials.gov ID
- NCT04553744
- Acronym / sponsor ID
- 2020-0099
- Conditions
- Soft Tissue Sarcoma, Lymph Node Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 0 participant accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 17 Sep 2020 (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 investigates the surgical management of lymph node basins for extremity and trunk soft tissue sarcoma (ETSTS) to identify and better understand the surgical practice patterns of sarcoma surgeons. ETSTS has been known to spread to distant locations including lymph nodes, with some subtypes of the disease spreading to lymph nodes more than others. This has led to sarcoma surgeons to treat patients differently from one another, including those with more lymph node involvement. The purpose of this study is to investigate the practice patterns of ETSTS surgeons.
Detailed description
PRIMARY OBJECTIVES:
- Identify the practice patterns of sarcoma surgeons with respect to management of lymph node basins for extremity and trunk soft tissue sarcomas (ETSTS).
II. Identify when surgeons would perform sentinel lymph node biopsy and/or lymph node dissection for ETSTS and if management differs for high-risk subtypes of sarcoma that are more likely to have nodal metastases.
III. Identify differences in practice patterns between surgical oncologists and orthopedic oncologic surgeons.
OUTLINE:
Participants complete an online survey over 5-10 minutes asking how they would manage lymph node basins in the extremity sarcoma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey) | – | Other: Survey AdministrationParticipants complete an online survey over 5-10 minutes asking how they would manage lymph node basins in the extremity sarcoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Practicing surgeons who are members of The Society of Surgical Oncology and Musculoskeletal Tumor Society, and treat extremity and trunk soft tissue sarcomas.
Key inclusion criteria (1 listed)
- Currently practicing surgeons who treat ETSTS and are members of The Society of Surgical Oncology and Musculoskeletal Tumor Society
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Survey AdministrationComplete survey | Other | Observational (survey) |
Primary outcome
Practice patterns of sarcoma surgeons
Time frame: Up to 2 years
Will identify the practice patterns of sarcoma surgeons with respect to management of lymph node basins for extremity and trunk soft tissue sarcomas (ETSTS).
Sentinel lymph node biopsy and/or lymph node dissection for ETSTS
Time frame: Up to 2 years
Will identify when surgeons would perform sentinel lymph node biopsy and/or lymph node dissection for ETSTS, and if management differs for high-risk subtypes of sarcoma that are more likely to have nodal metastases.
Differences in practice patterns
Time frame: Up to 2 years
Will identify differences in practice patterns between surgical oncologists and orthopedic oncologic surgeons.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Soft Tissue Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
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. This study is not recruiting at the moment.
Christina L Roland principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Sarcoma and Lymph Node Cancer, run by M.D. Anderson Cancer Center.
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 1 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: withdrawn, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Practice patterns of sarcoma surgeons (time frame: Up to 2 years). The study lists 3 primary outcomes in all. 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 29 Feb 2024.