Pan-tumor MRD Study

Inclusion 32

• Minimum age: 18 years
• Study condition: 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)
• Eligibility Criteria:
• Age 18 years or older.
• 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).
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.
• No systemic therapy for current cancer diagnosis administered before enrollment.
• Willing and able to comply with required study procedures, including blood sample collection and primary tumor tissue submission from diagnostic biopsy or surgical excision.
• 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).
• No concurrent diagnosis of another invasive cancer, except for nonmelanoma skin cancers.
• No prior allogeneic hematopoietic stem cell transplant.
• 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
• Muscle-invasive urothelial carcinoma of the bladder and Melanoma Cohorts: Stage II or operable III cancer:
• Esophageal, Gastric/GEJ, and NSCLC Cohorts: Stage I, II, or operable III cancer.
• Pancreatic Cohort: Stage I, II or operable III cancer, exocrine only disease.
• 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:
• Central nervous system (CNS) malignancies
• Colorectal cancer
• Breast cancer
• Squamous cell skin cancer
• Basal cell carcinoma
• Gastrointestinal stromal tumors (GIST)
• Thyroid cancer
• Uveal melanoma
• 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
• 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