Pan-tumor MRD Study

Launched by FLATIRON HEALTH · Sep 18, 2024

Keywords

ClinConnect Summary

The Pan-tumor MRD Study is a clinical trial aimed at improving our understanding of certain types of cancer, including muscle invasive bladder cancer, esophageal cancer, gastric cancer, melanoma, non-small cell lung cancer, and pancreatic cancer. The goal is to collect blood and tumor tissue samples from patients diagnosed with early to operable stage cancers. Researchers will use this information to develop better tests for detecting cancer and assessing the risk of it returning after treatment.

To participate, you must be at least 18 years old and have been diagnosed with a specific type of cancer that is eligible for surgery. You should not have received any treatment for your cancer before joining the study, and if you have had surgery, you should enroll within three months of that procedure. Throughout the study, which is expected to last about five and a half years, you will continue to receive your regular cancer care from your doctor. This trial is currently recruiting participants of all genders, and your involvement will help advance our knowledge of cancer and improve future treatments.

Gender

ALL

Eligibility criteria

• 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