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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.
Enrollment
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Inclusion and exclusion criteria
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
1,350 participants in 7 patient groups
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Central trial contact
Anosheh Afghahi, MD
Data sourced from clinicaltrials.gov
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