Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population: The INFORM Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorDana-Farber Cancer Institute
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- GRAIL Galleri Test
Treatment groups
1,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov