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RECRUITING

NCT06605404

Pan-tumor MRD Study

Sponsor: Paradigm Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1350

Start Date

2025-01-08

Completion Date

2032-04

Last Updated

2026-09-24

Healthy Volunteers

Conditions

Muscle Invasive Bladder Urothelial Carcinoma Esophageal Cancer Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma Melanoma (Skin Cancer)NSCLC (Non-small Cell Lung Cancer)Pancreatic (Exocrine Only)Mix of Solid Tumors (MOST)

Interventions

DIAGNOSTIC_TEST

blood and tissue samples

routine standard of care

OTHER

blood and tissue samples

Routine standard of care

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

Locations (47)

Alabama Oncology

Birmingham, Alabama, United States

Mohtaseb Cancer Center and Blood Disorders

Bullhead City, Arizona, United States

Cancer & Blood Specialists of Arizona

Casa Grande, Arizona, United States

CARTI

Little Rock, Arkansas, United States

Highlands Oncology Group (HOG)

Springdale, Arkansas, United States

Los Angeles Cancer Network (LACN)

Glendale, California, United States

Ventura County Hematology Oncology Specialists

Oxnard, California, United States

Medical Oncology Associates of San Diego (MOASD)

San Diego, California, United States

Medical Oncology Associates of San Diego

San Diego, California, United States

Stockton Hematology Oncology Med Group

Stockton, California, United States

The Melanoma and Skin Cancer Institute

Englewood, Colorado, United States

Oncology & Hematology Associates of West Broward

Coral Springs, Florida, United States

Mid Florida Cancer Centers

Orange City, Florida, United States

Comprehensive Hematology Oncology (CHO)

St. Petersburg, Florida, United States

Piedmont Cancer Institute

Atlanta, Georgia, United States

Cancer Care Specialists of Illinois (CCSI)

O'Fallon, Illinois, United States

Carle Health

Urbana, Illinois, United States

Cotton O'Neil Cancer Center [Stormont Vail]

Topeka, Kansas, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Baptist Health Corbin

Corbin, Kentucky, United States

Baptist Health Hardin

Elizabethtown, Kentucky, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Baptist Health Louisville

Louisville, Kentucky, United States

Pontchartrain Cancer Center

Covington, Louisiana, United States

Christus Health Highlands

Shreveport, Louisiana, United States

The Cancer & Hematology Centers (CHC)

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Cox Health

Springfield, Missouri, United States

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

Guthrie Lourdes Memorial Hospital (GLMH)

Binghamton, New York, United States

New York Cancer & Blood Specialists

Shirley, New York, United States

Carolina Oncology Specialists

Charlotte, North Carolina, United States

Southeastern Medical Oncology Center (SMOC)

Goldsboro, North Carolina, United States

Regional Medical Oncology Center

Wilson, North Carolina, United States

Gabrail Cancer Center

Canton, Ohio, United States

Taylor Cancer Research Center

Maumee, Ohio, United States

Oklahoma Cancer Specialists and Research Institute (OCSRI)

Tulsa, Oklahoma, United States

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Lancaster General Hospital (UPenn)

Lancaster, Pennsylvania, United States

Guthrie Foundation

Sayre, Pennsylvania, United States

Cancer Care Associates of York (CCAY)

York, Pennsylvania, United States

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

Houston, Texas, United States

Community Clinical Trials

Kingwood, Texas, United States

Christus St. Michael's

Texarkana, Texas, United States

Virginia Cancer Institute

Richmond, Virginia, United States

Northwest Medical Specialties (NWMS)

Tacoma, Washington, United States