Pan-tumor MRD Study

August 13, 2025 updated by: Flatiron Health

Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
    • Ohio
      • Maumee, Ohio, United States, 43437
        • Recruiting
        • Taylor Cancer Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)
Diagnostic test: blood and tissue samples
routine standard of care
Other: blood and tissue samples
Routine standard of care
Esophageal
Esophageal cancer
Diagnostic test: blood and tissue samples
routine standard of care
Other: blood and tissue samples
Routine standard of care
Gastric and Gastroesophageal Junction (GEJ)
Diagnostic test: blood and tissue samples
routine standard of care
Other: blood and tissue samples
Routine standard of care
Melanoma
Diagnostic test: blood and tissue samples
routine standard of care
Other: blood and tissue samples
Routine standard of care
Non-small cell lung (NSCLC)
Diagnostic test: blood and tissue samples
routine standard of care
Other: blood and tissue samples
Routine standard of care
Pancreatic (exocrine only)
Diagnostic test: blood and tissue samples
routine standard of care
Other: blood and tissue samples
Routine standard of care
Mix of Solid Tumors (MOST)
Diagnostic test: blood and tissue samples
routine standard of care
Other: blood and tissue samples
Routine standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood and tissue biospecimen registry
Time Frame: Observation from enrollment to 5.5 years after enrollment
To establish a blood and tissue biospecimen resource in participants with operable solid tumors, with clinical, lab, radiographic, and pathology annotation for the discovery, development, and validation of MRD assays.
Observation from enrollment to 5.5 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Flatiron Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

April 1, 2032

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FH-PrwS-07-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Cancer

Clinical Trials on blood and tissue samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe