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Pan-tumor MRD Study

Pan-tumor MRD Study

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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.
    1. 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 details
    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)

NCT06605404

Flatiron Health

15 October 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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