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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an investigational blood test called the GRAIL Galleri test, designed to detect many types of cancer early. This study focuses on people at slightly higher than average risk of developing certain cancers, including those with genetic cancer predisposition syndromes or a strong family history of cancer. The goal is to evaluate the benefits and possible harms of this multi-cancer early detection (MCED) test in a prospective, interventional setting lasting up to three years. Participants will undergo baseline questionnaires and a blood test using the Galleri MCED test. Depending on the test result, follow-up may vary: those with a negative test will have recommended cancer screenings and a follow-up phone call one year later, while those with a positive test may have additional clinic visits, lab tests, biopsies, surgeries, or imaging scans such as ultrasound, CT, or MRI. If cancer is confirmed, participants will complete a post-diagnostic questionnaire. During the study, participants will complete questionnaires and blood tests at scheduled visits. Researchers will monitor cancer detection rates up to two years and track outcomes like cancer stage at diagnosis, positive predictive value at 12 and 24 months, time to diagnostic resolution, participant anxiety, quality of life, and costs related to follow-up testing. The study expects to enroll about 1,000 people and lasts up to three years, including follow-up assessments and safety monitoring.
CONDITIONS
Brief 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 22 or older for patients with TP53 germline pathogenic variants; age 35 or older for other cancer predisposing gene variants
- Germline genetic testing showing pathogenic variants in cancer predisposing genes
- Clinically diagnosed Cancer Predisposition Syndromes such as neurofibromatosis, Fanconi Anemia, or Ataxia-Telangiectasia
- Age 45 or older for adults with family history suggesting elevated cancer risk not meeting Group 1 criteria
- Family history includes one or more first or second degree relatives with certain cancers at or before age 50, or multiple relatives with breast or prostate cancer at any age
You will not qualify if you...
- Diagnosis of invasive cancer within 3 years before enrollment
- Blood-based multi-cancer screening test within the last year
- Symptomatic or active cancer needing active treatment (except hormone therapy for breast/prostate cancer)
- Negative genetic test for familial germline mutation in Group 2 individuals
- Family history of sex-specific cancers not matching participant's sex
- Currently being evaluated for suspected cancer
- History of cancer risk-reducing surgery such as mastectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 3 years
Participants complete baseline questionnaires and blood tests for multi-cancer early detection and are monitored with follow-up assessments including recommended cancer screenings and a follow-up phone call 1 year after the initial blood test.
1 baseline visit and 1 follow-up phone call at 1 year
Duration - Up to 24 months
Participants with a positive multi-cancer early detection test may undergo additional clinic visits, lab tests, biopsies, surgical procedures, or imaging assessments to confirm cancer status.
Additional visits depending on test results and diagnostic procedures
Duration - Up to 2 years after diagnostic resolution
Participants with confirmed cancer complete post-diagnostic questionnaires and continue to be monitored for health outcomes.
Visits and assessments depending on individual cancer diagnosis and treatment
Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
E
Elizabeth ODonnell, MD
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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