New blood and urine tests for cancer screening
A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Mayo Clinic · NCT06192875
This study is testing new blood and urine tests for cancer screening to see how well they work in people without known cancer and how different health factors might affect the results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06192875 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish normal values for a novel blood and urine test designed for cancer screening. It will assess the distribution of methylated DNA tumor markers in patients without known cancer to determine specificity cutoffs. Additionally, the study will evaluate how demographic and health factors influence these marker levels and will build a biospecimen archive for future research. The feasibility of detecting cancer through urine and saliva samples will also be explored.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 and older without a known history of internal cancer.
Not a fit: Patients with a known internal cancer or a history of such cancers will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and non-invasive cancer screening methods.
How similar studies have performed: Other studies have explored similar molecular approaches to cancer detection, but this specific methodology is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: John B. Kisiel, M.D. — Mayo Clinic in Rochester
- Study coordinator: Ellie Omerdic
- Email: Omerdic.Ellie@mayo.edu
- Phone: 507-266-1874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm