RecruitingNCT06192875

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

Sponsor

Mayo Clinic

Enrollment

10,000 participants

Start Date

Sep 28, 2015

Study Type

OBSERVATIONAL

Conditions

Malignant Solid Neoplasm Hematopoietic and Lymphoid System Neoplasm

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

Min Age: 18 Years

Inclusion Criteria8

,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 Criteria10

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