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Hematopoietic and Lymphatic System NeoplasmNCT06304168

Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study

An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study explores the potential value of a new blood test approach for early detection of cancer. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Non-Interventional Study
How many people
6,150 participants
Where
1 siteUnited States
Study dates
13 May 2019to 15 May 2028
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: Cancer and control patients who will be seen or treated at Mayo clinic.

Who may be able to join

  • Aim 1 Tissue
  • Cases:
  • Patient has a biopsy confirmed diagnosis of target histology
  • Tissue samples from synchronous or metachronous primary cancers may be used as long as they are clearly of a different target organ.
  • Tumors from patients with an underlying genetic disorder pre-disposing to cancer may be included as long as they are stratified from those without
  • Controls:
Show all 17Show fewer
  • Patient does not have the diagnosis of target histology
  • Aim 2 Blood
  • Cases:
  • Patient has a biopsy confirmed diagnosis of target histology or radiographic criteria that are unequivocal for diagnosis (example, meets radiographic criteria for hepatocellular carcinoma)
  • Controls:
  • Patient does not have a documented diagnosis of cancer within 1 year following blood collections
  • Aim 3 Urine
  • Cases:
  • Patient has a biopsy confirmed diagnosis of target histology or radiographic criteria that are unequivocal for diagnosis (example, meets radiographic criteria for hepatocellular carcinoma)
  • Controls:
  • Patient does not have a diagnosis of the target histology

Who cannot join

  • Aim 1 Tissue
  • Cases and Controls:
  • Patient has had any transplants prior to tissue collection
  • Patient has received chemotherapy class drugs within 5 years prior to tissue collection
  • Cases:
  • Patient has had radiation to the current target lesion prior to tissue collection
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  • Patient has multi-centric/multi-focal breast cancer with differing genetic profiles (ER/HER2/PR status differ; if multiple masses are present and not all are tested then exclude patient)
  • Patient has bilateral breast cancer/Ductal carcinoma in situ (DCIS)
  • Aim 2 Blood
  • Controls:
  • Patient has known cancer prior to current sample acquisition (not including basal cell or squamous cell skin cancers) (if patient has not been seen or if information is not available, the patient is still eligible)
  • Cases:
  • Patient has known cancer outside of the target cancer 5 years prior to blood collection (not including basal cell or squamous cell skin cancers)
  • Patient has received chemotherapy class drugs in the 5 years prior to blood collection
  • Patient has had any prior radiation therapy to the target lesion prior to blood collection
  • Patient has had an intervention to completely remove current target pathology
  • The current target pathology is a recurrence
  • Patient has had a biopsy to the target organ and/or lesion within 3 days before blood collection
  • Aim 3 Urine
  • Patient has known cancer outside of the target cancer 5 years prior to urine collection (not including basal cell or squamous cell skin cancers)
  • Patient has received chemotherapy class drugs in the 5 years prior to urine collection
  • Patient has had any prior radiation therapy to the target lesion prior to urine collection
  • Patient has had a biopsy to the target organ and/or lesion within 3 days before urine collection
  • The current target pathology is a recurrence
  • Patient has chronic indwelling urinary catheter
  • Patient has had a urinary tract infection within the 14 days prior to sample collection
  • If patient does not have a primary bladder, ureter or urethral cancer, patient has a history of bladder ureter, or urethral cancer
  • Cases:
  • Patient has had an intervention to completely remove current target pathology
  • The current target pathology is a recurrence

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

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    John B. Kisiel, M.D.

    Recruiting

Other trials in United States

About this study

Official title: Validation of DNA Methylation Markers for the Universal and Site-Specific Guided Cancer Detection (the VANGUARD Study)

This study explores the potential value of a new blood test approach for early detection of cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Validate candidate universal and site-specific MDMs in DNA extracted from formalin-fixed paraffin embedded primary tumor and control specimens.

II. Test MDM-based models for detection of multi-cancers using a non-invasive biological medium, specifically blood.

III. Assess feasibility for detection of cancers using urine samples to assay MDMs, RNA or protein in cell free or extra-cellular vesicles; patients may be the same or unique individuals from Aim 1 and 2.

OUTLINE: This is an observational study.

Patients undergo blood, urine, and/or residual tissue sample collection and have their medical records reviewed on study.

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 groups in NCT06304168
Study groupRoleWhat they receive
ObservationalPatients undergo blood, urine, and/or residual tissue sample collection and have their medical records reviewed on study.
Receives: Other: Non-Interventional Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall cancer (Y/N) - blood test

    Blood samples will be assayed for known cancer markers to explore the potential value of a new blood test approach to detecting cancer. Accuracy of results may be evaluated based on review of past, present, and future medical record information.

    Measured: Baseline (samples collected at enrollment)

  2. Overall cancer (Y/N) - urine test

    Urine samples will be assayed for known cancer markers to explore the potential value of a new urine test approach to detecting cancer. Accuracy of results may be evaluated based on review of past, present, and future medical record information.

    Measured: Baseline (samples collected at enrollment)

  3. Cancer specific site prediction - blood samples/MDM

    Blood samples will be assayed for methylated DNA markers (MDMs) to identify individual organ sites of primary tumors.

    Measured: Baseline (samples collected at enrollment)

  4. Cancer specific site prediction - urine samples/MDM

    Urine samples will be assayed for methylated DNA markers (MDMs) to identify individual organ sites of primary tumors.

    Measured: Baseline (samples collected at enrollment)

  5. Cancer specific site prediction - blood samples/RNA

    Blood samples will be assayed for ribonucleic acid (RNA) to identify individual organ sites of primary tumors.

    Measured: Baseline (samples collected at enrollment)

  6. Cancer specific site prediction - urine samples/RNA

    Urine samples will be assayed for ribonucleic acid (RNA) to identify individual organ sites of primary tumors.

    Measured: Baseline (samples collected at enrollment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start13 May 2019
  3. Primary completion15 May 2028 (estimated)
  4. Study completion15 May 2028 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
6,150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06304168
Sponsor's protocol ID
19-000890
Other IDs
NCI-2024-00954, 19-000890
Status last verified
Aug 2026
First submitted
27 Feb 2024
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hematopoietic and Lymphatic 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 17 inclusion and 30 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 20 Aug 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall cancer (Y/N) - blood test (time frame: Baseline (samples collected at enrollment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06304168.

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 20 Aug 2026.

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