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

NCT ID: NCT06450171

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-27
• Study Completion Date: 2028-01-31

Brief 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.

Conditions

Cancer Predisposition Syndrome; Predisposition, Genetic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Galleri MCED Test

Participants will be enrolled and will complete:

• Baseline questionnaires and blood test.
• Post-test questionnaires.
• Follow-up assessments for a negative GRAIL Galleri test include recommended cancer screenings and a follow up phone call with study staff 1 year after the GRAIL Galleri blood test.
• Follow-up assessments for a positive GRAIL test may include clinic visits, lab tests with additional blood work-ups, biopsies, surgical procedures, or imaging assessments such as ultrasound, Computed Tomography (CT) scans, or an Magnetic Resonance Imaging (MRI) scans.
• If cancer status is confirmed, participants will complete a post-diagnostic questionnaire.

Group Type: EXPERIMENTAL

GRAIL Galleri Test

Intervention Type: OTHER

A multi-cancer early detection (MCED) blood test.

Interventions

GRAIL Galleri Test

A multi-cancer early detection (MCED) blood test.

Intervention Type: OTHER

Eligibility Criteria

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)
• 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 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)

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth ODonnell

Sponsor Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth ODonnell, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth ODonnell, MD

Role: CONTACT

dfciprevention@mgb.org

617-762-2334

Facility Contacts

Elizabeth ODonnell, MD

Role: primary

elizabeth_odonnell@dfci.harvard.edu

587-215-2361

Other Identifiers

24-070

Identifier Type: -

Identifier Source: org_study_id