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

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.

Eligibility

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

Conditions3

Locations1 site

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