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

Inclusion Criteria

• 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 Criteria

• 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