Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population: The INFORM Study
Dana-Farber Cancer Institute
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
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…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria Group 1- Cancer Predisposition Syndrome: * 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) Inclusion Criteria Group 2 - Familial Risk: * Age ≥ 45 * Adults with family history suggestive of e…
Interventions
- OtherGRAIL Galleri Test
A multi-cancer early detection (MCED) blood test.
Location
- Dana-Farber Cancer InstituteBoston, Massachusetts