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

Description

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

Cancer Predisposition Syndrome, Predisposition, Genetic

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Cancer Predisposition Syndrome
Intervention / Treatment

-

Contacts and Locations

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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)
  • * Individuals with known hematologic precursor disease (e.g. CHIP, MGUS, etc.)
  • * Individuals without English-language proficiency

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Dana-Farber Cancer Institute,

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

Study Record Dates

2028-01-31