An Investigational Screening Test (MCED) for Early Detection of Cancer in a High-Risk Population, the INFORM Study

Status: active

This clinical trial tests how well GRAIL Galleri, registered trademark, multi-cancer early detection (MCED) test works in identifying cancer early in people that are at higher risk of developing certain types of cancers. The MCED, a next-generation sequencing-based screening test, looks for small pieces of genetic material, called deoxyribonucleic acid (DNA), in the blood that may indicate the presence of cancer. This test may be able to identify if cancer is present and may also be able to suggest what type of cancer is present.

Inclusion Criteria

GROUP I CANCER PREDISPOSITION SYNDROME: Age ≥ 22 for patients with TP53 germline pathogenic variants, age ≥ 35 for all other variants in cancer predisposing genes
GROUP I CANCER PREDISPOSITION SYNDROME: Germline genetic testing revealed pathogenic germline variants in cancer predisposing genes (list of genes typically tested listed in pre-screening document)
GROUP I CANCER PREDISPOSITION SYNDROME: Individuals with a clinically based diagnosis of a cancer predisposition syndrome (examples, neurofibromatosis, Fanconi anemia, ataxia-telangiectasia)
GROUP II FAMILIAL RISK: Age ≥ 45
GROUP II FAMILIAL RISK: 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 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)

PRIMARY OBJECTIVE:

I. To identify the number and types of cancers diagnosed by MCED screening in a high-risk population.

SECONDARY OBJECTIVES:

I. To evaluate stages of cancer diagnosed by MCED testing in a high-risk patient population.

II. To evaluate the positive predictive value (PPV) of the GRAIL Galleri® MCED test in a high-risk patient population based on cancer status assessments at 12 months.

III. To evaluate the PPV of the GRAIL Galleri® MCED test in a high-risk patient population based on cancer status assessments at 24 months.

IV. To evaluate time needed to achieve diagnostic resolution following a signal positive test.

V. To assess the number and types of testing needed to achieve diagnostic resolution following a signal positive test.

VI. To evaluate anxiety in patients participating in MCED testing.

VII. To evaluate quality of life in patients participating in MCED testing.

VIII. To assess economic burden of follow-up testing among participants screened with a MCED test.

IX. To assess financial reimbursement to the institution for diagnostic tests ordered as a result of a positive MCED test.

OUTLINE:

Participants undergo blood sample collection for MCED testing at baseline. Participants with positive results undergo standard of care diagnostic workup for the suspected cancer(s). If no cancer is found on workup, participants undergo additional blood sample collection for MCED testing at 6 and 12 months after initial testing. Participants with negative results receive results and recommendations to follow guideline-recommended cancer screening.

After completion of study intervention, patients with a positive screen result are followed up at 12 and 24 months or until diagnosed with an invasive cancer. Patients with a negative screen result are followed up at 12 months.

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An Investigational Screening Test (MCED) for Early Detection of Cancer in a High-Risk Population, the INFORM Study

Inclusion Criteria

Exclusion Criteria

United States

Massachusetts

Boston

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An Investigational Screening Test (MCED) for Early Detection of Cancer in a High-Risk Population, the INFORM Study

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