Pan-tumor MRD Study

NCT06605404 | Recruiting

• 1 other identifier: FH-PrwS-07-002
• Study Type: observational
• Target: 1,350
• Locations: 1 country
• Sites: 2

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); Pancreatic (Exocrine Only); Mix of Solid Tumors (MOST)

Keywords

observational; biospecimen; routine care

Outcome Measures

Primary Outcomes (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.

  Observation from enrollment to 5.5 years after enrollment

Study Arms (7)

Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)

Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)

Diagnostic Test: blood and tissue samples; Other: blood and tissue samples

Esophageal

Esophageal cancer

Diagnostic Test: blood and tissue samples; Other: blood and tissue samples

Gastric and Gastroesophageal Junction (GEJ)

Gastric and Gastroesophageal Junction (GEJ)

Diagnostic Test: blood and tissue samples; Other: blood and tissue samples

Melanoma

Melanoma

Diagnostic Test: blood and tissue samples; Other: blood and tissue samples

Non-small cell lung (NSCLC)

Non-small cell lung (NSCLC)

Diagnostic Test: blood and tissue samples; Other: blood and tissue samples

Pancreatic (exocrine only)

Pancreatic (exocrine only)

Diagnostic Test: blood and tissue samples; Other: blood and tissue samples

Mix of Solid Tumors (MOST)

Mix of Solid Tumors (MOST)

Diagnostic Test: blood and tissue samples; Other: blood and tissue samples

Interventions

blood and tissue samples DIAGNOSTIC_TEST

routine standard of care

Esophageal; Gastric and Gastroesophageal Junction (GEJ); Melanoma; Mix of Solid Tumors (MOST); Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC); Non-small cell lung (NSCLC); Pancreatic (exocrine only)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender as defined at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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. 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Paradigm Health: lead

Study Sites (2)

Medical Oncology Associates of San Diego

San Diego, California, 92123, United States

RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, 43437, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and tissue samples

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma; Melanoma; Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Anosheh Afghahi, MD

CONTACT

888-662-6367; anosheh.afghahi@flatiron.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): April 1, 2032
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)