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INFORM Study: Early Cancer Detection for High-Risk Individuals

This study is evaluating the GRAIL Galleri Test, a blood test designed to find many types of cancer early. We want to see how well this test works and if there are any downsides for people who have a higher chance of getting cancer due to a Cancer Predisposition Syndrome (a genetic condition that increases cancer risk). The study will measure how many cancers are detected by the test over two years. You might be able to join if you are at least 22 years old and have certain genetic changes, like a TP53 germline pathogenic variant, that put you at higher risk for cancer. The study is currently unclear on its recruitment status.

Study design
This is an interventional study, meaning participants will receive the GRAIL Galleri Test. About 1,000 people are expected to participate.
What's involved
Participation involves screening for eligibility, blood tests, questionnaires, and clinic visits. Your involvement in the study is expected to last up to 3 years.
Compensation
Not stated in the trial record.
Follow-up
The study will track cancer detection rates for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06450171

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

Recruiting
NAAges 22+InterventionalScreening
Dana-Farber Cancer Institute
~1,000 participants
Updated 2026-01-20 on ClinicalTrials.gov
What's tested:GRAIL Galleri Test

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cancer Detection Rate
Measured over Up to 2 years

Conditions

Cancer Predisposition Syndrome
Predisposition, Genetic

Explore related trials

Hereditary Malignant NeoplasmPredisposition to Malignant NeoplasmCancer predisposing genesTP53 Gene

NCT06450171

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana-Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Elizabeth ODonnell, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Elizabeth ODonnell, MD
[email protected]
617-762-2334
Email the study team

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Eligibility criteria

Inclusion

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)
Neuroendocrine cancer or tumors (any age)
Metastatic prostate cancer (any age)
Multiple primary cancers (example bilateral breast cancer)
≥ 2 first or second degree relative on same side of the family (any combination is acceptable) with breast or prostate cancer at any age

Exclusion

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)

What this trial measures

  • Cancer Detection RateUp to 2 years

    Descriptive statistics will be used to summarize the number and types of cancers diagnosed by GRAIL Galleri MCED testing.