RECRUITING

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

Conditions

Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2015-09-28

Study Completion:2035-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06192875

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

John B. Kisiel, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-09-28

Study Completion Date2035-12

Study Record Updates

Study Start Date2015-09-28

Study Completion Date2035-12

Terms related to this study

Additional Relevant MeSH Terms

Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm