A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
10,000 patients without a known internal (non-cutaneous) cancer or a history of an internal cancer
To balance age, rough recruitment goals will be set for the following subsets: 18-39 years, 40-49 years , 50-59 years , 60-69 years , 70-79 years , and >= 80 years
To balance sex, roughly half of the participants recruited within each age subset will be women
Roughly half of all participants will have had a colonoscopy or colon x-ray within the past 5 years, or Cologuard® test in the last 3 years which were negative for cancer and precancerous lesions
Disqualifiers
Patients has a past or current diagnosis of invasive cancer (this does not include basal cell or squamous cell skin cancers)
Patient has had a solid organ transplant
Inability to give informed consent
Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection
Trial population
Patients without a known internal (non-cutaneous) cancer or a history of an internal cancer
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
Blood level distributions of methylated DNA tumor markers
Assessed through assays performed on blood plasma across a cohort of patients without known cancer or precancer to estimate specificity cutoff ranges.
Time frame
Baseline2
Biospecimen archive
Assessed by total number of blood samples collected. Collected blood samples will be used to facilitate assessment of clinical specificity in future molecular blood test studies or appraisal of test refinements.
Time frame
Up to study completion (estimate 20 years)3
Detection of cancer using urine samples
Assessed by number of urine samples used to assay methylated DNA markers (MDMs), RNA, or protein in cell free or extracellular vesicles.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov