Status:
RECRUITING
A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Lead Sponsor:
Mayo Clinic
Conditions:
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
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 r...
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 specificit...
Eligibility Criteria
Inclusion
- 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
- Roughly half of all participants will have had a chest x-ray within the past 5 years which was negative for cancer
- Roughly half of women participants will have had a mammography in the past 5 years which was negative for cancer
- An attempt will be made to recruit minimums (parentheses) of the following subsets: men with normal Prostate-specific antigen (PSA) level (200); diabetes mellitus (200); connective tissue diseases like rheumatoid arthritis, systemic lupus erythematosus, and scleroderma (100); chronic obstructive lung disease (100); inflammatory bowel disease or cirrhosis (100), and pancreatitis (100)
- To assess the effects of other common covariates, specific recruitment targets will not be set. Rather, data obtained on all participants will include BMI, smoking (past/present), alcohol consumption, pregnant status (women), and selected medications (steroidal and non-steroidal anti-inflammatory drugs, statins, anti-hypertensives, and anti-depressants)
Exclusion
- 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
- URINE EXCLUSIONS
- Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection
- Patient has chronic indwelling urinary catheter
- Patient has had a urinary tract infection within the 14 days prior to sample collection
- SALIVA EXCLUSIONS
- Patient has known clinically significant xerostomia
- Patient has known recent (within 30 days prior to collection) active upper respiratory tract infection or anogenital infection
Key Trial Info
Start Date :
September 28 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2035
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT06192875
Start Date
September 28 2015
End Date
December 1 2035
Last Update
October 2 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905