New blood and urine tests for cancer screening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.