Actively Recruiting
A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Led by Mayo Clinic · Updated on 2026-03-10
10000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new molecular approach to cancer screening by studying blood, urine, and saliva samples. This observational study aims to establish normal values for specific methylated DNA tumor markers in people without known cancer or precancer. It also explores how demographic factors, exposures, medications, and chronic diseases may affect these marker levels. The study is sponsored by the Mayo Clinic and includes building a biospecimen archive to support future research in molecular blood tests for cancer detection. Participants provide blood and urine samples for analysis, and saliva samples are also assessed for markers like methylated DNA, RNA, or proteins found in cell-free or extracellular vesicles. The study involves reviewing patients' medical records and collecting demographic and health information. Recruitment targets aim to balance age groups, sex, and certain health conditions to better understand marker distributions. This approach helps evaluate the specificity of these markers in cancer screening. During the study, participants undergo sample collections and medical record reviews at baseline. The primary outcomes include measuring blood levels of methylated DNA tumor markers, assessing cancer detection feasibility using urine samples, and establishing a long-term biospecimen archive extending up to 20 years. The study includes healthy volunteers aged 18 and older, with ongoing monitoring to support future molecular blood test advancements for cancer detection.
CONDITIONS
Brief Title
A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older without a known internal (non-cutaneous) cancer or history of invasive cancer
- Balanced recruitment across age groups: 18-39, 40-49, 50-59, 60-69, 70-79, and 80 years or older
- Roughly equal numbers of men and women in each age group
- About half of participants have had a negative colonoscopy, colon x-ray, or Cologuard test within the past 3 to 5 years
- About half have had a negative chest x-ray within the past 5 years
- About half of women have had a negative mammography in the past 5 years
- Recruitment targets include subsets with normal PSA levels in men, diabetes, connective tissue diseases, chronic lung disease, inflammatory bowel disease or cirrhosis, and pancreatitis
- Collection of data on BMI, smoking history, alcohol use, pregnancy status, and selected medications
You will not qualify if you...
- Past or current diagnosis of invasive cancer (excluding basal or squamous cell skin cancers)
- History of solid organ transplant
- Unable to give informed consent
- For urine samples: recent urinary tract infection, urinary catheter use, or transurethral instrumentation within specified timeframes
- For saliva samples: known significant dry mouth or recent active upper respiratory or anogenital infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Baseline assessment
Participants provide blood, urine, and saliva samples and have their medical records reviewed to assess molecular markers and collect data on health and exposures.
1 visit (in-person)
Duration - Up to 20 years
Participants are followed over time to build a biospecimen archive and support future assessments of test specificity and feasibility.
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
E
Ellie Omerdic
C
Clinical Trials Referral Office
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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