Recruiting

MRD

Sponsor:

Flatiron Health

Code:

NCT06605404

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Esophageal Cancer

Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Melanoma (Skin Cancer)

NSCLC (Non-small Cell Lung Cancer)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

blood and tissue samples

blood and tissue samples

Study Details

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.

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Esophageal Cancer

Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Melanoma (Skin Cancer)

NSCLC (Non-small Cell Lung Cancer)

Study ID

NCT06605404

Start date

Jan 8, 2025

Status verified date

Aug, 2025

Completion date

Apr, 2032

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1350 participants

Anticipated

Interventions and Outcome Measures

Arms

Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)

Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)

Esophageal

Esophageal cancer

Gastric and Gastroesophageal Junction (GEJ)

Gastric and Gastroesophageal Junction (GEJ)

Melanoma

Melanoma

Non-small cell lung (NSCLC)

Non-small cell lung (NSCLC)

Pancreatic (exocrine only)

Pancreatic (exocrine only)

Mix of Solid Tumors (MOST)

Mix of Solid Tumors (MOST)

Interventions

blood and tissue samples

routine standard of care

blood and tissue samples

Routine standard of care

Primary outcome measure

  • Blood and tissue biospecimen registry [ Time Frame: Observation from enrollment to 5.5 years after enrollment ]

Central Contacts and Locations

Central contacts

Locations

Medical Oncology Associates of San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43437

Contacts

More Information

Sponsor

Flatiron Health

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Keywords

  • observational
  • biospecimen
  • routine care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Flatiron Health on 2025-08-14.