Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population: The INFORM Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GRAIL Galleri Test.
- Who it may be relevant to
- Registry conditions: Cancer Predisposition Syndrome, Predisposition, Genetic. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other GRAIL Galleri Test
A multi-cancer early detection (MCED) blood test.
Primary outcome measures
- Cancer Detection Rate [Time frame: Up to 2 years]
Secondary outcome measures (9)
- Stage of Invasive Cancer Diagnosis [Time frame: Up to 2 years]
- Positive Predictive Value At 12 Months [Time frame: At 12 months]
- Positive Predictive Value at 24 Months [Time frame: At 24 months]
- Time to Diagnostic Resolution [Time frame: Calculated from the date of return of screening results (up to 4 weeks from baseline) until up to 24 months post screening]
- Test Type Utilization to Diagnostic Resolution [Time frame: Up to 24 months]
- Change in Participant Anxiety [Time frame: Up to 24 months]
- Change in Participant Health-related Quality of Life [Time frame: Up to 24 months]
- Cost of Follow-up Testing [Time frame: Up to 24 months]
- Institutional Reimbursement of Follow-up Testing [Time frame: Up to 24 months]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT06450171 · 24-070