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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Hematopoietic and Lymphoid System Neoplasm
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Mayo Clinic,

John B. Kisiel, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2035-12