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

Malignant Solid Neoplasm Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06192875
Study type Observational
Source Mayo Clinic
Contact
Status Recruiting
Phase
Start date September 28, 2015
Completion date December 2035
View Details
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