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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06450171
Status
Recruiting
Apply to this trial

Conditions

  • Cancer Predisposition Syndrome
  • Predisposition, Genetic

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • GRAIL Galleri Test — OTHER
    A multi-cancer early detection (MCED) blood test.

Study Details

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

Key Dates

Start date
Sep 27, 2024
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: 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.

Primary Outcome Measure

Cancer Detection Rate [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Elizabeth ODonnell, MD
[email protected]
587-215-2361
Elizabeth ODonnell, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MA

Related Studies