Recruiting

MRD

Sponsor:

Paradigm Health

Code:

NCT06605404

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Esophageal Cancer

Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Melanoma (Skin Cancer)

NSCLC (Non-small Cell Lung Cancer)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

blood and tissue samples

blood and tissue samples

Study Details

Brief 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. 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.

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Esophageal Cancer

Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Melanoma (Skin Cancer)

NSCLC (Non-small Cell Lung Cancer)

Study ID

NCT06605404

Start date

Jan 8, 2025

Status verified date

Sep, 2026

Completion date

Apr, 2032

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

a. If surgical resection has occurred, enrollment should occur within 3 months of surgical resection and before initiation of adjuvant therapy.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.
5. No systemic therapy for current cancer diagnosis administered before enrollment.
6. Willing and able to comply with required study procedures, including blood sample collection and primary tumor tissue submission from diagnostic biopsy or surgical excision.
7. 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).
8. No concurrent diagnosis of another invasive cancer, except for nonmelanoma skin cancers.
9. No prior allogeneic hematopoietic stem cell transplant.
10. 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
11. Muscle-invasive urothelial carcinoma of the bladder and Melanoma Cohorts: Stage II or operable III cancer:
12. Esophageal, Gastric/GEJ, and NSCLC Cohorts: Stage I, II, or operable III cancer.
13. Pancreatic Cohort: Stage I, II or operable III cancer, exocrine only disease.
14. 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

Study Design

Enrollment

1350 participants

Anticipated

Interventions and Outcome Measures

Arms

Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)

Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)

Esophageal

Esophageal cancer

Gastric and Gastroesophageal Junction (GEJ)

Gastric and Gastroesophageal Junction (GEJ)

Melanoma

Melanoma

Non-small cell lung (NSCLC)

Non-small cell lung (NSCLC)

Pancreatic (exocrine only)

Pancreatic (exocrine only)

Mix of Solid Tumors (MOST)

Mix of Solid Tumors (MOST)

Interventions

blood and tissue samples

routine standard of care

blood and tissue samples

Routine standard of care

Primary outcome measure

  • Blood and tissue biospecimen registry [ Time Frame: Observation from enrollment to 5.5 years after enrollment ]

Central Contacts and Locations

Central contacts

Locations

Alabama Oncology

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Principal Investigator:

Carter Capra

Mohtaseb Cancer Center and Blood Disorders

Recruiting

Bullhead City, Arizona, United States, 86442

Contacts

Principal Investigator:

Hamdy Mohtaseb

Cancer & Blood Specialists of Arizona

Recruiting

Casa Grande, Arizona, United States, 85122

Contacts

Principal Investigator:

Carlos Arce-Lara

CARTI

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Principal Investigator:

Andrew Briggler

Highlands Oncology Group (HOG)

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Principal Investigator:

Joseph Beck

Los Angeles Cancer Network (LACN)

Recruiting

Glendale, California, United States, 91204

Contacts

Principal Investigator:

Peyman Salimi-Tari

Ventura County Hematology Oncology Specialists

Recruiting

Oxnard, California, United States, 93030

Contacts

Principal Investigator:

Lynn Kong

Medical Oncology Associates of San Diego (MOASD)

Recruiting

San Diego, California, United States, 92123

Contacts

Principal Investigator:

James Coggan

Medical Oncology Associates of San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

Stockton Hematology Oncology Med Group

Recruiting

Stockton, California, United States, 95204

Contacts

Principal Investigator:

Sunny Phillip

The Melanoma and Skin Cancer Institute

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Principal Investigator:

Ryan Weight

Oncology & Hematology Associates of West Broward

Recruiting

Coral Springs, Florida, United States, 33065

Contacts

Principal Investigator:

Sumit Sawhney

Mid Florida Cancer Centers

Recruiting

Orange City, Florida, United States, 32763

Contacts

Principal Investigator:

Santosh Nair

Comprehensive Hematology Oncology (CHO)

Recruiting

St. Petersburg, Florida, United States, 33709

Contacts

Principal Investigator:

Neeharika Makani

Piedmont Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Principal Investigator:

Vasileios Assikis

Cancer Care Specialists of Illinois (CCSI)

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

James Wade

Carle Health

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Christine Canfield

Cotton O'Neil Cancer Center [Stormont Vail]

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Principal Investigator:

Mehmmod Hashmi

Cancer Center of Kansas

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Principal Investigator:

Shaker Dakhil

Baptist Health Corbin

Recruiting

Corbin, Kentucky, United States, 40701

Contacts

Principal Investigator:

Abigail Byrnes

Baptist Health Hardin

Recruiting

Elizabethtown, Kentucky, United States, 42701

Contacts

Principal Investigator:

Christopher Burkeen

Baptist Health Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Principal Investigator:

Arvinda Padmanabhan

Baptist Health Louisville

Recruiting

Louisville, Kentucky, United States, 40207

Contacts

Principal Investigator:

Wangjian Zhong

Pontchartrain Cancer Center

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Principal Investigator:

David Oubre

Christus Health Highlands

Recruiting

Shreveport, Louisiana, United States, 71105

Contacts

Principal Investigator:

Neelima Chintapalli

The Cancer & Hematology Centers (CHC)

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Principal Investigator:

Joy Bartholomew

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Lisa Boardman

Cox Health

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Principal Investigator:

Rajesh Banderudrappagari

Cancer Partners of Nebraska

Recruiting

Lincoln, Nebraska, United States, 68516

Contacts

Principal Investigator:

Stacey Knox

San Juan Oncology Associates

Recruiting

Farmington, New Mexico, United States, 87401

Contacts

Principal Investigator:

Sardar Imam

Guthrie Lourdes Memorial Hospital (GLMH)

Recruiting

Binghamton, New York, United States, 13905

Contacts

Principal Investigator:

Beka Aroshidze

New York Cancer & Blood Specialists

Recruiting

Shirley, New York, United States, 11967

Contacts

Principal Investigator:

Richard Zuniga

Carolina Oncology Specialists

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Principal Investigator:

Justin Favaro

Southeastern Medical Oncology Center (SMOC)

Recruiting

Goldsboro, North Carolina, United States, 27534

Contacts

Principal Investigator:

Samer Kasbari

Regional Medical Oncology Center

Recruiting

Wilson, North Carolina, United States, 27893

Contacts

Principal Investigator:

Keith Lerro

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

Contacts

Principal Investigator:

Nashat Gabrail

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43437

Contacts

Oklahoma Cancer Specialists and Research Institute (OCSRI)

Recruiting

Tulsa, Oklahoma, United States, 74129

Contacts

Principal Investigator:

Scott Cole

Oregon Health & Science University (OHSU)

Recruiting

Portland, Oregon, United States, 97201

Contacts

Principal Investigator:

Nima Nabavizadeh

Lancaster General Hospital (UPenn)

Recruiting

Lancaster, Pennsylvania, United States, 17601

Contacts

Principal Investigator:

Efrat Dotan

Guthrie Foundation

Recruiting

Sayre, Pennsylvania, United States, 18840

Contacts

Principal Investigator:

Rebekah Macfie

Cancer Care Associates of York (CCAY)

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Principal Investigator:

Chanh Huynh

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

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Julio Peguero

Community Clinical Trials

Recruiting

Kingwood, Texas, United States, 77339

Contacts

Principal Investigator:

Saleha Sajid

Christus St. Michael's

Recruiting

Texarkana, Texas, United States, 75503

Contacts

Principal Investigator:

Sunil Patel

Virginia Cancer Institute

Recruiting

Richmond, Virginia, United States, 23229

Contacts

Principal Investigator:

Susan Moore

Northwest Medical Specialties (NWMS)

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Principal Investigator:

Manas Agastya

More Information

Sponsor

Paradigm Health

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • observational
  • biospecimen
  • routine care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Paradigm Health on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.