Hematopoietic and Lymphoid System NeoplasmNCT06192875
A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
An observational study of Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2015to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients without a known internal (non-cutaneous) cancer or a history of an internal cancer
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Ellie Omerdic, 507-266-1874, Omerdic.Ellie@mayo.edu
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
About this 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Assess feasibility for detection of cancer using saliva to assay MDMs, RNA or protein in cell free or extra-cellular vesicles.
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo blood and urine sample collection on study. Patients' medical records are reviewed. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start28 Sep 2015
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John B. Kisiel, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192875
- Sponsor's protocol ID
- 15-006191
- Other IDs
- NCI-2023-09354, 15-006191
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
- ClinicalTrials.gov ID
- NCT06192875
- Acronym / sponsor ID
- 15-006191
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Sep 2015 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
- Assess feasibility for detection of cancer using saliva to assay MDMs, RNA or protein in cell free or extra-cellular vesicles.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo blood and urine sample collection on study. Patients' medical records are reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients without a known internal (non-cutaneous) cancer or a history of an internal cancer
Key inclusion criteria (8 listed)
- 10,000 patients without a known internal (non-cutaneous) cancer or a history of an internal cancer
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Blood level distributions of methylated DNA tumor markers
Time frame: Baseline
Assessed through assays performed on blood plasma across a cohort of patients without known cancer or precancer to estimate specificity cutoff ranges.
Biospecimen archive
Time frame: Up to study completion (estimate 20 years)
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.
Detection of cancer using urine samples
Time frame: Baseline
Assessed by number of urine samples used to assay methylated DNA markers (MDMs), RNA, or protein in cell free or extracellular vesicles.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John B. Kisiel, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellie Omerdic (507-266-1874, Omerdic.Ellie@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood level distributions of methylated DNA tumor markers (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.