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

NCT06192875 | Recruiting

• 2 other identifiers: 15-006191NCI-2023-09354
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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

Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm

Outcome Measures

Primary Outcomes (3)

• Blood level distributions of methylated DNA tumor markers

  Assessed through assays performed on blood plasma across a cohort of patients without known cancer or precancer to estimate specificity cutoff ranges.

  Baseline

• Biospecimen archive

  Assessed by total number of blood samples collected. Collected blood samples will be used to facilitate assessment of clinical specificity in future molecular blood test studies or appraisal of test refinements.

  Up to study completion (estimate 20 years)

• Detection of cancer using urine samples

  Assessed by number of urine samples used to assay methylated DNA markers (MDMs), RNA, or protein in cell free or extracellular vesicles.

  Baseline

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients without a known internal (non-cutaneous) cancer or a history of an internal cancer

You may qualify if:

• ,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)

You may not qualify if:

• 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
• 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
• Patient has known clinically significant xerostomia
• Patient has known recent (within 30 days prior to collection) active upper respiratory tract infection or anogenital infection

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

With participant permission, samples will be stored for future research. If future studies examine DNA and findings are noted, the participant will be notified.

Study Officials

• John B. Kisiel, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellie Omerdic

CONTACT

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

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: September 28, 2015
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)