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

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)