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Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population: The INFORM Study | Clinical Trials | Clareo Health

RECRUITINGNA

Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population: The INFORM Study

NCT06450171•Dana-Farber Cancer Institute

View on ClinicalTrials.gov

Summary

The purpose of this research study is to evaluate the possible benefits and harms of screening with an investigational blood test designed to detect many types of cancer early. The name of the screening blood test being studied is: -GRAIL Galleri test

Detailed Description

This is a prospective, interventional study to assess the use of the GRAIL's Galleri multi-cancer early detection (MCED) Test, an investigational blood test designed to detect many types of cancer, for participants that are considered at slightly higher than average risk of developing certain types of cancers. The test looks for small pieces of genetic material called deoxyribonucleic acid (DNA) in the blood that may indicate the presence of cancer. The research study procedures include screening for eligibility, blood tests, questionnaires, and clinic visits. Participation in this research study is expected to last up to 3 years. It is expected that about 1,000 people will take part in this research study.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age ≥ 22 for patients with TP53 germline pathogenic variants, age ≥ 35 for all other variants in cancer predisposing genes
•Germline genetic testing revealed pathogenic germline variants in cancer predisposing genes (list of genes typically tested listed in pre-screening document)
•Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia)
•Age ≥ 45
•Adults with family history suggestive of elevated cancer risk as defined by any the criteria below, who do not fall into Group 1:
•* ≥ 1 first or second degree relative on same side of the family with:
•* Breast, colon, gastric, endometrial, kidney cancer at or before age 50
•* Triple negative breast cancer (any age)
•* Male breast cancer (any age)
•* Ovarian, pancreatic, sarcoma cancer (any age)
+4 more criteria

Exclusion Criteria

•Individuals diagnosed with invasive malignancy within 3 years of enrollment
•Have had a blood-based multi-cancer screening test within last year
•Individuals with evidence of symptomatic or active cancer requiring active therapeutic intervention at the time of participation (hormone therapy for breast/prostate cancer is considered acceptable and will not preclude participation)
•Individuals in Group 2 whose family history of cancer was the result of a germline mutation in a cancer predisposing gene and who have tested negative for that same familial germline mutation
•Individuals in Group 2 whose family history of cancer is sex-specific and who is a different sex than the proband with cancer (e.g., a male with a family history of endometrial or ovarian cancer would not be eligible)
•Individuals in process of being evaluated for clinical suspicion of cancer
•Individuals who have undergone a cancer risk-reducing surgery for hereditary cancer risk (e.g., mastectomy)

Locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

September 27, 2024

Primary Completion Date

January 31, 2027

Completion Date

January 31, 2028

Last Updated

January 20, 2026

Enrollment

1,000

ESTIMATED participants

Conditions

Cancer Predisposition SyndromePredisposition, Genetic

Interventions

GRAIL Galleri Test

OTHER

Contacts

Elizabeth ODonnell, MD

CONTACT

617-762-2334 dfciprevention@mgb.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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