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NCT06605404 | RECRUITING | Muscle Invasive Bladder Urothelial Carcinoma

Pan-tumor MRD Study
Sponsor:

Flatiron Health

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.

Condition or disease

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)

Intervention/treatment

blood and tissue samples

blood and tissue samples

Study Type : OBSERVATIONAL
Estimated Enrollment : 1350 participants
Official Title : Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2031-12
Estimated Study Completion Date : 2032-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Pan-tumor MRD Study

Location Details

NCT06605404

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Ohio

Taylor Cancer Research Center

Maumee, Ohio, United States, 43437