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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm
• Intervention / Treatment: Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVES:

I. To assess blood level distributions of candidate methylated DNA tumor markers across a cohort of patients without known cancer or precancer and, thereby, to estimate specificity cutoffs across a range of percentiles.

II. To evaluate the effects on marker levels (or test specificity) of selected demographic, exposure, medication, and chronic disease covariates.

III. To build a biospecimen archive to facilitate assessment of clinical specificity in future molecular blood test studies or appraisal of test refinements.

IV. Assess feasibility for detection of cancer using urine samples to assay MDMs, RNA or protein in cell free or extra-cellular vesicles.

V. Assess feasibility for detection of cancer using saliva to assay MDMs, RNA or protein in cell free or extra-cellular vesicles.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: John B. Kisiel, M.D.
      • Contact: Jackie Arndt; Phone Number: 507-266-3966; Email: Arndt.Jacquelyn@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients undergo blood and urine sample collection on study. Patients' medical records are reviewed.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: John B. Kisiel, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2015
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 15-006191 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2023-09354 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No