Evaluating a blood test for early cancer detection in high-risk individuals
Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population: The INFORM Study
This study is testing a blood test that aims to find different types of cancer early in people who are at higher risk for developing the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06450171 on ClinicalTrials.gov |
What this trial studies
This research evaluates the GRAIL Galleri multi-cancer early detection test, which is designed to identify various types of cancer through a blood sample. The study targets individuals at higher-than-average risk for developing cancer, including those with specific genetic predispositions or family histories of cancer. Participants will undergo eligibility screening, blood tests, and complete questionnaires over a period of up to three years, with an expected enrollment of around 1,000 individuals.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 22 and older with known cancer predisposition syndromes or those aged 45 and older with a significant family history of certain cancers.
Not a fit: Patients without a family history of cancer or those under the age thresholds for the specified genetic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of multiple cancers, potentially improving treatment outcomes for high-risk patients.
How similar studies have performed: Other studies have shown promise in using similar multi-cancer early detection approaches, but this specific test and population focus may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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)
Where this trial is running
Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth ODonnell, MD — Dana-Farber Cancer Institute
- Study coordinator: Elizabeth ODonnell, MD
- Email: dfciprevention@mgb.org
- Phone: 617-762-2334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.