Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1350 participants
OBSERVATIONAL
2025-01-08
2032-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)
Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)
blood and tissue samples
routine standard of care
blood and tissue samples
Routine standard of care
Esophageal
Esophageal cancer
blood and tissue samples
routine standard of care
blood and tissue samples
Routine standard of care
Gastric and Gastroesophageal Junction (GEJ)
Gastric and Gastroesophageal Junction (GEJ)
blood and tissue samples
routine standard of care
blood and tissue samples
Routine standard of care
Melanoma
Melanoma
blood and tissue samples
routine standard of care
blood and tissue samples
Routine standard of care
Non-small cell lung (NSCLC)
Non-small cell lung (NSCLC)
blood and tissue samples
routine standard of care
blood and tissue samples
Routine standard of care
Pancreatic (exocrine only)
Pancreatic (exocrine only)
blood and tissue samples
routine standard of care
blood and tissue samples
Routine standard of care
Mix of Solid Tumors (MOST)
Mix of Solid Tumors (MOST)
blood and tissue samples
routine standard of care
blood and tissue samples
Routine standard of care
Interventions
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blood and tissue samples
routine standard of care
blood and tissue samples
Routine standard of care
Eligibility Criteria
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Inclusion Criteria
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
â– 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
18 Years
ALL
No
Sponsors
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Flatiron Health
INDUSTRY
Responsible Party
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Locations
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Medical Oncology Associates of San Diego
San Diego, California, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FH-PrwS-07-002
Identifier Type: -
Identifier Source: org_study_id
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