RECRUITING

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

Conditions

Cancer Predisposition Syndrome Predisposition, Genetic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-12

Study Completion:2028-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06450171

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.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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

Contacts and Locations

Study Contact

Elizabeth ODonnell, MD

CONTACT

617-762-2334

dfciprevention@mgb.org

Principal Investigator

Elizabeth ODonnell, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12

Study Completion Date2028-01-31

Study Record Updates

Study Start Date2024-12

Study Completion Date2028-01-31

Terms related to this study

Keywords Provided by Researchers

Cancer Predisposition Syndrome
Predisposition, Genetic

Additional Relevant MeSH Terms

Cancer Predisposition Syndrome
Predisposition, Genetic