Spots Global Cancer Trial Database for A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)

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Trial Identification

Brief Title: A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)

Official Title: A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)

Study ID: NCT06192875

Conditions

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Interventions

Non-Interventional Study

Study Description

Brief Summary: This study is being done to establish "normal' values for a new blood test and urine test approach to cancer screening. Patients undergo blood and urine sample collection on study. Patients' medical records are reviewed.

Detailed Description: PRIMARY OBJECTIVES: I. To assess blood level distributions of candidate methylated DNA tumor markers across a cohort of patients without known cancer or precancer and, thereby, to estimate specificity cutoffs across a range of percentiles. II. To evaluate the effects on marker levels (or test specificity) of selected demographic, exposure, medication, and chronic disease covariates. III. To build a biospecimen archive to facilitate assessment of clinical specificity in future molecular blood test studies or appraisal of test refinements. IV. Assess feasibility for detection of cancer using urine samples to assay MDMs, RNA or protein in cell free or extra-cellular vesicles. V. Assess feasibility for detection of cancer using saliva to assay MDMs, RNA or protein in cell free or extra-cellular vesicles.