Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population: The INFORM Study
- Conditions
- Cancer Predisposition SyndromePredisposition, Genetic
- Interventions
- Other: GRAIL Galleri Test
- Registration Number
- NCT06450171
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief 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
- Detailed 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 study is expected to last up to 3 years.
It is expected that about 1,000 people will take part in this research study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
- 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 Group 2 whose family history of cancer is sex-specific and who is a different sex than the proband with cancer (e.g., a male with a family history of endometrial or ovarian cancer would not be eligible)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Galleri MCED Test GRAIL Galleri 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 Measures
Name Time Method Cancer Detection Rate Up to 2 years Descriptive statistics will be used to summarize the number and types of cancers diagnosed by GRAIL Galleri MCED testing.
- Secondary Outcome Measures
Name Time Method Change in Participant Health-related Quality of Life Up to 24 months Changes in health-related quality of life following the GRAIL Galleri MCED test result and assessed by PROMIS Scale v1.2 - Global Health, a 10 item survey that is rated on a 5-point Likert scale with answers ranging from "Excellent/Completely/Never/None" to "Poor/Not at all/Always/Very Severe" and includes a pain average question rated on a scale of 0 "No Pain" to 10 "Worst Pain Imaginable." The range of scoring is from 9 to 45 with higher scores indicating higher quality of life.
Stage of Invasive Cancer Diagnosis Up to 2 years 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.
Positive Predictive Value At 12 Months 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.
Positive Predictive Value at 24 Months 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 to Diagnostic Resolution Calculated from the date of return of screening results (up to 4 weeks from baseline) until up to 24 months post screening Defined as the time required to achieve diagnostic resolution following a "signal detected" GRAIL Galleri MCED test result.
Change in Participant Anxiety Up to 24 months Changes in anxiety following the GRAIL Galleri MCED test result and assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Emotional Distress Anxiety - Short Form 6a, which is a 6 item survey that is rated on a 5-point Likert scale with answers ranging from "Never" to "Always". The range of scoring is from 6 to 30 with higher scores indicating greater severity of anxiety.
Test Type Utilization to Diagnostic Resolution Up to 24 months Per participant the count of the number and types of diagnostic tests required to achieve diagnostic resolution following a "signal detected" GRAIL Galleri MCED test result.
Cost of Follow-up Testing Up to 24 months Defined as the dollar cost, per participant, of follow-up testing to achieve diagnostic resolution following a "signal detected" GRAIL Galleri MCED test result.
Institutional Reimbursement of Follow-up Testing Up to 24 months Defined as the dollar cost, per participant, of the institutional reimbursement of follow-up testing to achieve diagnostic resolution following a "signal detected" GRAIL Galleri MCED test result.
Trial Locations
- Locations (1)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States