NCT06192875 A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
| NCT ID | NCT06192875 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Hematopoietic and Lymphoid System Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2015-09-28 |
| Primary Completion | 2035-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2015-09-28 with a primary completion date of 2035-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
John B. Kisiel, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06192875 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematopoietic and Lymphoid System Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06192875 currently recruiting?
Yes, NCT06192875 is actively recruiting participants. Contact the research team at Omerdic.Ellie@mayo.edu for enrollment information.
Where is the NCT06192875 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06192875 clinical trial?
NCT06192875 is sponsored by Mayo Clinic. The principal investigator is John B. Kisiel, M.D. at Mayo Clinic in Rochester. The trial plans to enroll 10,000 participants.