Recruiting

Cancer Screening

Sponsor:

Mayo Clinic

Code:

NCT06192875

Conditions

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Non-Interventional Study

Study Details

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT06192875

Start date

Sep 28, 2015

Status verified date

Mar, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo blood and urine sample collection on study. Patients' medical records are reviewed.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Blood level distributions of methylated DNA tumor markers [ Time Frame: Baseline ]
  • Biospecimen archive [ Time Frame: Up to study completion (estimate 20 years) ]
  • Detection of cancer using urine samples [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Ellie Omerdic

507-266-1874Omerdic.Ellie@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Ellie Omerdic

507-266-1874Omerdic.Ellie@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

John B. Kisiel, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-10.