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Recruiting Observational

Pan-tumor MRD Study

NCT06605404 · tracked via the Priya Life Science USA tracker
Sponsor
Paradigm Health
Phase
Observational
Started
2025-01-08
Last updated
2026-09-24

Condition(s) studied

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)

Investigational drug(s) / intervention(s)

blood and tissue samplesblood and tissue samples

blood and tissue samples: routine standard of care

blood and tissue samples: Routine standard of care

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Blood and tissue biospecimen registry — Observation from enrollment to 5.5 years after enrollment
    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.

Trial sites (47)

FacilityCityRegionStatus
Alabama Oncology Birmingham Alabama Recruiting
Mohtaseb Cancer Center and Blood Disorders Bullhead City Arizona Recruiting
Cancer & Blood Specialists of Arizona Casa Grande Arizona Recruiting
CARTI Little Rock Arkansas Recruiting
Highlands Oncology Group (HOG) Springdale Arkansas Recruiting
Los Angeles Cancer Network (LACN) Glendale California Recruiting
Ventura County Hematology Oncology Specialists Oxnard California Recruiting
Medical Oncology Associates of San Diego (MOASD) San Diego California Recruiting
Medical Oncology Associates of San Diego San Diego California Recruiting
Stockton Hematology Oncology Med Group Stockton California Recruiting
The Melanoma and Skin Cancer Institute Englewood Colorado Recruiting
Oncology & Hematology Associates of West Broward Coral Springs Florida Recruiting
Mid Florida Cancer Centers Orange City Florida Recruiting
Comprehensive Hematology Oncology (CHO) St. Petersburg Florida Recruiting
Piedmont Cancer Institute Atlanta Georgia Recruiting
Cancer Care Specialists of Illinois (CCSI) O'Fallon Illinois Recruiting
Carle Health Urbana Illinois Recruiting
Cotton O'Neil Cancer Center [Stormont Vail] Topeka Kansas Recruiting
Cancer Center of Kansas Wichita Kansas Recruiting
Baptist Health Corbin Corbin Kentucky Recruiting
Baptist Health Hardin Elizabethtown Kentucky Recruiting
Baptist Health Lexington Lexington Kentucky Recruiting
Baptist Health Louisville Louisville Kentucky Recruiting
Pontchartrain Cancer Center Covington Louisiana Recruiting
Christus Health Highlands Shreveport Louisiana Recruiting
The Cancer & Hematology Centers (CHC) Grand Rapids Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Cox Health Springfield Missouri Recruiting
Cancer Partners of Nebraska Lincoln Nebraska Recruiting
San Juan Oncology Associates Farmington New Mexico Recruiting
Guthrie Lourdes Memorial Hospital (GLMH) Binghamton New York Recruiting
New York Cancer & Blood Specialists Shirley New York Recruiting
Carolina Oncology Specialists Charlotte North Carolina Recruiting
Southeastern Medical Oncology Center (SMOC) Goldsboro North Carolina Recruiting
Regional Medical Oncology Center Wilson North Carolina Recruiting
Gabrail Cancer Center Canton Ohio Recruiting
Taylor Cancer Research Center Maumee Ohio Recruiting
Oklahoma Cancer Specialists and Research Institute (OCSRI) Tulsa Oklahoma Recruiting
Oregon Health & Science University (OHSU) Portland Oregon Recruiting
Lancaster General Hospital (UPenn) Lancaster Pennsylvania Recruiting

+ 7 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06605404 on ClinicalTrials.gov ↗ ← All trials in the USA