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

Predisposition, Genetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450171
• Other study ID #: 24-070
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: January 31, 2028

Study information

• Verified date: June 2024
• Source: Dana-Farber Cancer Institute
• Contact: Elizabeth ODonnell, MD
• Phone: 587-215-2361
• Email: elizabeth_odonnell[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: January 31, 2028
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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 elevated cancer risk as defined by any the criteria below, who do not fall into Group 1:

• >1 first or second degree relative on same side of the family with:

• Breast, colon, gastric, endometrial, kidney cancer at or before age 50

• Triple negative breast cancer (any age)

• Male breast cancer (any age)

• Ovarian, pancreatic, sarcoma cancer (any age)

• Neuroendocrine cancer or tumors (any age)

• Metastatic prostate cancer (any age)

• Multiple primary cancers (example bilateral breast cancer)

• >2 first or second degree relative on same side of the family (any combination is acceptable) with breast or prostate cancer at any age

Exclusion Criteria:

• 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 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

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition to Disease
• Predisposition, Genetic

Intervention

Other:
• GRAIL Galleri Test
A multi-cancer early detection (MCED) blood test.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer Detection Rate	Descriptive statistics will be used to summarize the number and types of cancers diagnosed by GRAIL Galleri MCED testing.	Up to 2 years
Secondary	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.	Up to 2 years
Secondary	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.	At 12 months
Secondary	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.	At 24 months
Secondary	Time to Diagnostic Resolution	Defined as the time required to achieve diagnostic resolution following a "signal detected" GRAIL Galleri MCED test result.	Calculated from the date of return of screening results (up to 4 weeks from baseline) until up to 24 months post screening
Secondary	Test Type Utilization to Diagnostic Resolution	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.	Up to 24 months
Secondary	Change in Participant Anxiety	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.	Up to 24 months
Secondary	Change in Participant Health-related Quality of Life	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.	Up to 24 months
Secondary	Cost of Follow-up Testing	Defined as the dollar cost, per participant, of follow-up testing to achieve diagnostic resolution following a "signal detected" GRAIL Galleri MCED test result.	Up to 24 months
Secondary	Institutional Reimbursement of Follow-up Testing	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.	Up to 24 months