Actively Recruiting
Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population: The INFORM Study
Led by Dana-Farber Cancer Institute · Updated on 2026-01-20
1000
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population: The INFORM Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 for patients with TP53 germline pathogenic variants, age 35 for all other variants in cancer predisposing genes
- Germline genetic testing shows pathogenic variants in cancer predisposing genes
- Clinical diagnosis of a Cancer Predisposition Syndrome (e.g., neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia)
- Adults aged 45 or older with family history suggesting elevated cancer risk not in Group 1
- Family history includes 1 first or second degree relative with early-onset breast, colon, gastric, endometrial, or kidney cancer
- Family history includes triple negative breast cancer at any age
- Family history includes male breast cancer at any age
- Family history includes ovarian, pancreatic, sarcoma cancer at any age
- Family history includes neuroendocrine cancer or tumors at any age
- Family history includes metastatic prostate cancer at any age
- Family history includes multiple primary cancers (e.g., bilateral breast cancer)
- Family history includes 2 first or second degree relatives with breast or prostate cancer at any age
You will not qualify if you...
- Diagnosed with invasive malignancy within 3 years prior to enrollment
- Had a blood-based multi-cancer screening test within the last year
- Active symptomatic cancer requiring therapeutic intervention (hormone therapy for breast/prostate cancer allowed)
- Group 2 individuals with family history due to a known familial germline mutation but tested negative for it
- Group 2 individuals whose family history is sex-specific but participant is opposite sex (e.g., male with family history of ovarian or endometrial cancer)
- Currently being evaluated for suspected cancer
- Underwent cancer risk-reducing surgery for hereditary cancer risk (e.g., mastectomy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
E
Elizabeth ODonnell, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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