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NCT06605404Recruiting

Pan-tumor MRD Study

Paradigm Health

Start Date

1/8/2025

Completion Date

4/1/2032

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DIAGNOSTIC_TEST

blood and tissue samples

OTHER

blood and tissue samples

Interested in This Trial?

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Conditions

Muscle Invasive Bladder Urothelial CarcinomaEsophageal CancerGastric and Gastroesophageal Junction (GEJ) AdenocarcinomaMelanoma (Skin Cancer)NSCLC (Non-small Cell Lung Cancer)Pancreatic (Exocrine Only)Mix of Solid Tumors (MOST)

Locations

Alabama Oncology

Birmingham, Alabama 35205

United States

Mohtaseb Cancer Center and Blood Disorders

Bullhead City, Arizona 86442

United States

Cancer & Blood Specialists of Arizona

Casa Grande, Arizona 85122

United States

CARTI

Little Rock, Arkansas 72205

United States

Highlands Oncology Group (HOG)

Springdale, Arkansas 72762

United States

Los Angeles Cancer Network (LACN)

Glendale, California 91204

United States

Ventura County Hematology Oncology Specialists

Oxnard, California 93030

United States

Medical Oncology Associates of San Diego (MOASD)

San Diego, California 92123

United States

Medical Oncology Associates of San Diego

San Diego, California 92123

United States

Stockton Hematology Oncology Med Group

Stockton, California 95204

United States

The Melanoma and Skin Cancer Institute

Englewood, Colorado 80113

United States

Oncology & Hematology Associates of West Broward

Coral Springs, Florida 33065

United States

Mid Florida Cancer Centers

Orange City, Florida 32763

United States

Comprehensive Hematology Oncology (CHO)

St. Petersburg, Florida 33709

United States

Piedmont Cancer Institute

Atlanta, Georgia 30318

United States

Cancer Care Specialists of Illinois (CCSI)

O'Fallon, Illinois 62269

United States

Carle Health

Urbana, Illinois 61801

United States

Cotton O'Neil Cancer Center [Stormont Vail]

Topeka, Kansas 66606

United States

Cancer Center of Kansas

Wichita, Kansas 67214

United States

Baptist Health Corbin

Corbin, Kentucky 40701

United States

Baptist Health Hardin

Elizabethtown, Kentucky 42701

United States

Baptist Health Lexington

Lexington, Kentucky 40503

United States

Baptist Health Louisville

Louisville, Kentucky 40207

United States

Pontchartrain Cancer Center

Covington, Louisiana 70433

United States

Christus Health Highlands

Shreveport, Louisiana 71105

United States

The Cancer & Hematology Centers (CHC)

Grand Rapids, Michigan 49546

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Cox Health

Springfield, Missouri 65807

United States

Cancer Partners of Nebraska

Lincoln, Nebraska 68516

United States

San Juan Oncology Associates

Farmington, New Mexico 87401

United States

Guthrie Lourdes Memorial Hospital (GLMH)

Binghamton, New York 13905

United States

New York Cancer & Blood Specialists

Shirley, New York 11967

United States

Carolina Oncology Specialists

Charlotte, North Carolina 28207

United States

Southeastern Medical Oncology Center (SMOC)

Goldsboro, North Carolina 27534

United States

Regional Medical Oncology Center

Wilson, North Carolina 27893

United States

Gabrail Cancer Center

Canton, Ohio 44718

United States

Taylor Cancer Research Center

Maumee, Ohio 43437

United States

Oklahoma Cancer Specialists and Research Institute (OCSRI)

Tulsa, Oklahoma 74129

United States

Oregon Health & Science University (OHSU)

Portland, Oregon 97201

United States

Lancaster General Hospital (UPenn)

Lancaster, Pennsylvania 17601

United States

Guthrie Foundation

Sayre, Pennsylvania 18840

United States

Cancer Care Associates of York (CCAY)

York, Pennsylvania 17403

United States

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

Houston, Texas 77030

United States

Community Clinical Trials

Kingwood, Texas 77339

United States

Christus St. Michael's

Texarkana, Texas 75503

United States

Virginia Cancer Institute

Richmond, Virginia 23229

United States

Northwest Medical Specialties (NWMS)

Tacoma, Washington 98405

United States