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

Launched by MAYO CLINIC · Dec 21, 2023

Keywords

ClinConnect Summary

The NOMAD Study is researching a new way to screen for cancer using blood and urine tests. The goal is to establish what is considered "normal" results for these tests in people who do not have a known history of internal cancer. To do this, the study will involve collecting blood and urine samples from about 10,000 participants, along with reviewing their medical records. This research aims to help detect cancers of the blood and lymphatic systems, as well as solid tumors, earlier and more accurately.

To participate in this study, individuals must be 18 years or older and should not have any known internal cancers. The researchers are looking to include a diverse group of people across different ages and genders, with specific targets to ensure a balanced representation. Participants can expect to provide blood and urine samples and will also have their medical history reviewed to ensure they meet the study criteria. It’s important to know that individuals with a current or past diagnosis of invasive cancer, certain recent medical procedures, or specific health conditions may not be eligible for this study.

Gender

ALL

Eligibility criteria

• 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