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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
GRAIL Galleri Test
Other interventionA multi-cancer early detection (MCED) blood test.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Galleri MCED TestExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cancer Detection Rate
Descriptive statistics will be used to summarize the number and types of cancers diagnosed by GRAIL Galleri MCED testing.
Time frame
Up to 2 yearsSecondary outcomes
1
Stage of Invasive Cancer Diagnosis
Descriptive statistics will be used to summarize the stages of invasive cancer that are diagnosed by GRAIL Galleri MCED testing and assessed by medical record review.
Time frame
Up to 2 years2
Positive Predictive Value At 12 Months
Positive Predictive Value is defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" on GRAIL Galleri MCED test results.
Time frame
At 12 months3
Positive Predictive Value at 24 Months
Positive Predictive Value is defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" on GRAIL Galleri MCED test results.
Time frame
At 24 months4
Time to Diagnostic Resolution
Defined as the time required to achieve diagnostic resolution following a "signal detected" GRAIL Galleri MCED test result.
Time frame
Calculated from the date of return of screening results (up to 4 weeks from baseline) until up to 24 months post screeningSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov