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Sponsor: National Cancer Institute (NCI)
Conditions: Bladder Carcinoma, Breast Carcinoma, Colorectal Carcinoma, Esophageal Carcinoma, Gastric Carcinoma
Interventions: Biospecimen Collection, Device Usage, Electronic Health Record Review, Multi-Cancer Detection Test, Multi-Cancer Detection Test
Countries: United States
The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).
Sex: ALL
Age: 45 Years to 75 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Ages 45-75 years old * Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment * Agree to allow collection of information from their medical records for study-related purposes * Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic * Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion Exclusion Criteria: * Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years * Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible. Persons with a history of prostate cancer that has not been treated are not eligible, regardless of when the diagnosis occurred * Ongoing cancer diagnostic work-up * Ongoing participation in another study of an investigational cancer screening test or technology not currently utilized in routine clinical practice * Currently breastfeeding or pregnant, or planning to become pregnant in the next year * History of solid organ or hematopoietic transplantation at any time, or blood transfusion within the last 30 days
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