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Muscle Invasive Bladder Urothelial CarcinomaNCT06605404

Pan-tumor MRD Study

An observational study of Muscle Invasive Bladder Urothelial Carcinoma and Esophageal Cancer, run by Paradigm Health at 47 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
blood and tissue samples
How many people
1,350 participants
Where
47 sitesUnited States
Study dates
8 Jan 2025to Apr 2032
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Study participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors

Eligibility Criteria:

  1. Age 18 years or older.
  2. Confirmed histological or cytological diagnosis of a malignant solid tumor that is either specified in one of the pre-defined tumor cohorts or meets the enrollment criteria for the Mix of Solid Tumors (MOST) cohort (Table 1).
  3. Eligible for curative intent therapy, with surgical resection of cancer planned.
  4. If surgical resection has occurred, enrollment should occur within 3 months of surgical resection and before initiation of adjuvant therapy.
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.
  6. No systemic therapy for current cancer diagnosis administered before enrollment.
  7. Willing and able to comply with required study procedures, including blood sample collection and primary tumor tissue submission from diagnostic biopsy or surgical excision.
  8. Has completed all therapy (including endocrine therapy) 3 or more years ago for any previous invasive solid organ malignancy (with exception of nonmelanoma skin cancers) or hematologic malignancy. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment (no washout period required).
  9. No concurrent diagnosis of another invasive cancer, except for nonmelanoma skin cancers.
  10. No prior allogeneic hematopoietic stem cell transplant.
  11. Able and willing to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information. Cohort Specific Criteria
  12. Muscle-invasive urothelial carcinoma of the bladder and Melanoma Cohorts: Stage II or operable III cancer:
  13. Esophageal, Gastric/GEJ, and NSCLC Cohorts: Stage I, II, or operable III cancer.
  14. Pancreatic Cohort: Stage I, II or operable III cancer, exocrine only disease.
  15. MOST cohort: Stage II or operable stage III solid tumor diagnosis that meets eligibility criteria and is not included in the other cohorts.

The following tumor types are excluded:

  1. Central nervous system (CNS) malignancies
  2. Colorectal cancer
  3. Breast cancer
  4. Squamous cell skin cancer
  5. Basal cell carcinoma
  6. Gastrointestinal stromal tumors (GIST)
  7. Thyroid cancer
  8. Uveal melanoma
  9. Low or intermediate grade neuroendocrine tumors ■ Eligible tumor types: High-grade neuroendocrine tumors, including neuroendocrine carcinomas, Merkel cell carcinomas, and small cell lung cancer are permissible
  10. Hematologic cancers including multiple myeloma or other plasma cell dyscrasias, Hodgkin\'s lymphoma, non-Hodgkin\'s lymphoma, acute or chronic leukemias including chronic lymphocytic leukemia / small lymphocytic leukemia

Trial locations and contacts

47 sites in 1 country. Contact the study team or a site near you to ask about taking part.

47 sites in 1 country

United States47 sites, 47 recruiting
  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

    Katie Adams, 678-298-3238, kadams@piedmontcancerinstitute.com

    Vasileios Assikis

    Recruiting
  • Guthrie Lourdes Memorial Hospital (GLMH)

    Binghamton, New York, 13905

    Colleen English, (607)798-5734, colleenh.english@guthrie.org

    Beka Aroshidze

    Recruiting
  • Alabama Oncology

    Birmingham, Alabama, 35205

    Kailee Hawkins, 919-368-3285, kailee.hawkins@alabamaoncology.com

    Carter Capra

    Recruiting
  • Mohtaseb Cancer Center and Blood Disorders

    Bullhead City, Arizona, 86442

    Stephanye Vargas, 928-219-4560, stephanye@azcancerandblood.com

    Hamdy Mohtaseb

    Recruiting
  • Gabrail Cancer Center

    Canton, Ohio, 44718

    Carrie Smith, 330-417-8231, csmith@gabrailcancercenter.com

    Nashat Gabrail

    Recruiting
  • Cancer & Blood Specialists of Arizona

    Casa Grande, Arizona, 85122

    Robin Wilson, 520-836-9800, robin.wilson@aoncology.com

    Carlos Arce-Lara

    Recruiting
  • Carolina Oncology Specialists

    Charlotte, North Carolina, 28207

    Tine Ekhaiyeme, 704-342-1900 Ext 1126, aekhaiyeme@carolinaonco.com

    Justin Favaro

    Recruiting
  • Oncology & Hematology Associates of West Broward

    Coral Springs, Florida, 33065

    Margie Murillo, 954 726 0035 x1230, margie.murillo@ohawb.com

    Sumit Sawhney

    Recruiting
  • Baptist Health Corbin

    Corbin, Kentucky, 40701

    Janie Platt, 859.260.6406, Janie.platt@bhsi.com

    Abigail Byrnes

    Recruiting
  • Pontchartrain Cancer Center

    Covington, Louisiana, 70433

    Ella Hunter, 985-419 0025, ella@pcclouisiana.com

    David Oubre

    Recruiting
  • Baptist Health Hardin

    Elizabethtown, Kentucky, 42701

    Kristen Lerch, 270-979-2686, Kristen.Lerch@bhsi.com

    Christopher Burkeen

    Recruiting
  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

    Sydney Harris, 720-316-8091 extn 101, sydney.harris@theskincancerinstitute.com

    Ryan Weight

    Recruiting
  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

    Jessica Barnes, (505)564-6850 ext 875, jessica@sjonc.com

    Sardar Imam

    Recruiting
  • Los Angeles Cancer Network (LACN)

    Glendale, California, 91204

    Robert Milford, (323) 794-1132 Ext: 3734, robert.milford@lahomg.com

    Peyman Salimi-Tari

    Recruiting
  • Southeastern Medical Oncology Center (SMOC)

    Goldsboro, North Carolina, 27534

    Mackenzie Lupton, 919-429-4318, mlupton@cancersmoc.com

    Samer Kasbari

    Recruiting
  • The Cancer & Hematology Centers (CHC)

    Grand Rapids, Michigan, 49546

    Maci Deboer, (616) 954-5550 Ext. 1925, mdeboer@hcwm.com

    Joy Bartholomew

    Recruiting
  • Onocology Consultants P.A. (Oncology Consultants [OC Houston])

    Houston, Texas, 77030

    Marisol Dominguez, (832) 333-1480, marisol.dominguez@aoncology.com

    Julio Peguero

    Recruiting
  • Community Clinical Trials

    Kingwood, Texas, 77339

    Kemi Stewart, 325-298-7478, kemi@communityclinicaltrials.com

    Saleha Sajid

    Recruiting
  • Lancaster General Hospital (UPenn)

    Lancaster, Pennsylvania, 17601

    Susan Tollett, 717-544-0511, susan.tollett@pennmedicine.upenn.edu

    Efrat Dotan

    Recruiting
  • Baptist Health Lexington

    Lexington, Kentucky, 40503

    Tory Tincher, 859.260.6464, Tory.Tincher@bhsi.com

    Arvinda Padmanabhan

    Recruiting
  • Cancer Partners of Nebraska

    Lincoln, Nebraska, 68516

    Candice Toombs, 402-327-7363, candicet@cancerpartners.com

    Stacey Knox

    Recruiting
  • CARTI

    Little Rock, Arkansas, 72205

    Carla Randall, 501-906-3012, Crandall@carti.com

    Andrew Briggler

    Recruiting
  • Baptist Health Louisville

    Louisville, Kentucky, 40207

    Kelly Strange, 502.928.6103, Kelly.Strange@bhsi.com

    Wangjian Zhong

    Recruiting
  • Taylor Cancer Research Center

    Maumee, Ohio, 43437

    Jennifer Martinez, 419-479-5605 ext. ext 4134, jmartinez@toledoclinic.com

    Recruiting
  • Cancer Care Specialists of Illinois (CCSI)

    O'Fallon, Illinois, 62269

    Kaitlynn Zeisset, 618-589-9721, kzeisset@ccsci.net

    James Wade

    Recruiting
  • Mid Florida Cancer Centers

    Orange City, Florida, 32763

    Kiran Penta, 386-538-3169, Kiran@aocorp.com

    Santosh Nair

    Recruiting
  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

    Cheryl Senour, 805-485-8709 x 121, csenour@venturaoncology.com

    Lynn Kong

    Recruiting
  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97201

    Francis DeAsis, (503) 418-8155, deasis@ohsu.edu

    Nima Nabavizadeh

    Recruiting
  • Virginia Cancer Institute

    Richmond, Virginia, 23229

    Christine Mathews, 1-804-287-3000 ext 1260, cmathews@vacancer.com

    Susan Moore

    Recruiting
  • Mayo Clinic

    Rochester, Minnesota, 55905

    Lauren Helgeson, 507-266-3718, helgeson.lauren@mayo.edu

    Lisa Boardman

    Recruiting
  • Medical Oncology Associates of San Diego (MOASD)

    San Diego, California, 92123

    Amanda Somo, (858) 637-7888 ext 224, asomo@oncologysandiego.com

    James Coggan

    Recruiting
  • Medical Oncology Associates of San Diego

    San Diego, California, 92123

    Alexis Bustamante, abustamante@oncologysandiego.com

    Recruiting
  • Guthrie Foundation

    Sayre, Pennsylvania, 18840

    Jackie Cole, (570)887-6071, jacqueline.cole@guthrie.org

    Rebekah Macfie

    Recruiting
  • New York Cancer & Blood Specialists

    Shirley, New York, 11967

    Stella Smaragdas, 631-675-5075, ssmaragdas@nycancer.com

    Richard Zuniga

    Recruiting
  • Christus Health Highlands

    Shreveport, Louisiana, 71105

    Nancy Hassan, 318.681.4763, nancy.senniah@christushealth.org

    Neelima Chintapalli

    Recruiting
  • Highlands Oncology Group (HOG)

    Springdale, Arkansas, 72762

    Tina Patrick, 479-872-8130, tpatrick@hogonc.com

    Joseph Beck

    Recruiting
  • Cox Health

    Springfield, Missouri, 65807

    Tala Abu Zahra, 417-269-7114, Tala.AbuZahra@coxhealth.com

    Rajesh Banderudrappagari

    Recruiting
  • Comprehensive Hematology Oncology (CHO)

    St. Petersburg, Florida, 33709

    Raj Shah, 727-344-6569 Ext 1036, rshah@comphemonc.com

    Neeharika Makani

    Recruiting
  • Stockton Hematology Oncology Med Group

    Stockton, California, 95204

    Lenzi Cook, 209-938-3106, lcook@shomg.net

    Sunny Phillip

    Recruiting
  • Northwest Medical Specialties (NWMS)

    Tacoma, Washington, 98405

    Erma Sanders, 253-428-8700, esanders@nwmsonline.com

    Manas Agastya

    Recruiting
  • Christus St. Michael's

    Texarkana, Texas, 75503

    Kimberly Everett, 903-614-6885, kimberly.everett@christushealth.org

    Sunil Patel

    Recruiting
  • Cotton O'Neil Cancer Center [Stormont Vail]

    Topeka, Kansas, 66606

    Scott Harrison, 785-270-4962, saharris@stormontvail.org

    Mehmmod Hashmi

    Recruiting
  • Oklahoma Cancer Specialists and Research Institute (OCSRI)

    Tulsa, Oklahoma, 74129

    Stephanie Sandoval, 918-568-6759, stephanie.sandoval@ocsri.org

    Scott Cole

    Recruiting
  • Carle Health

    Urbana, Illinois, 61801

    Christine Canfield, (217) 326-0095, christine.canfield@carle.com

    Christine Canfield

    Recruiting
  • Cancer Center of Kansas

    Wichita, Kansas, 67214

    Kristen Mazowiecki, (316) 613-4326, kristen.mazowiecki@cancercenterofkansas.com

    Shaker Dakhil

    Recruiting
  • Regional Medical Oncology Center

    Wilson, North Carolina, 27893

    Meredith Best, (252) 991-5261, meredith.best@regionaloncology.com

    Keith Lerro

    Recruiting
  • Cancer Care Associates of York (CCAY)

    York, Pennsylvania, 17403

    Clarissa Vega, 717-741-9229 EXT: 147, cvega@cancercareyork.com

    Chanh Huynh

    Recruiting

Other trials in United States

About this study

Official title: Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers

The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. The information collected will be used to develop tests to better understand cancer, for example, to improve cancer detection and to assess the risk of cancer coming back.

Participants will receive routine standard of care from their doctor and their involvement is expected to last for approximately five and a half (5.5) years.

Being tested
blood and tissue samples
Keywords
observational, biospecimen, routine care
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma, Melanoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood and tissue samplesDiagnostic test

    routine standard of care

  • blood and tissue samplesOther

    Routine standard of care

Study groups in NCT06605404
Study groupRoleWhat they receive
Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)
Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples
EsophagealEsophageal cancer
Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples
Gastric and Gastroesophageal Junction (GEJ)Gastric and Gastroesophageal Junction (GEJ)
Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples
MelanomaMelanoma
Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples
Non-small cell lung (NSCLC)Non-small cell lung (NSCLC)
Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples
Pancreatic (exocrine only)Pancreatic (exocrine only)
Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples
Mix of Solid Tumors (MOST)Mix of Solid Tumors (MOST)
Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood and tissue biospecimen registry

    To establish a blood and tissue biospecimen resource in participants with operable solid tumors, with clinical, lab, radiographic, and pathology annotation for the discovery, development, and validation of MRD assays.

    Measured: Observation from enrollment to 5.5 years after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2024
  2. Study start8 Jan 2025
  3. Primary completionDec 2031 (estimated)
  4. Study completionApr 2032 (estimated)

Resources

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
1,350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06605404
Sponsor's protocol ID
PHPE-07-002
Status last verified
Sep 2026
First submitted
18 Sep 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Muscle Invasive Bladder Urothelial Carcinoma and Esophageal Cancer, run by Paradigm Health at 47 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. 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 Anosheh Afghahi, MD (888-662-6367, anosheh.afghahi@paradigmhealth.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood and tissue biospecimen registry (time frame: Observation from enrollment to 5.5 years after enrollment). 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 24 Sep 2026.

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