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VANGUARD Study: Validating DNA Methylation Markers for Cancer Detection

The VANGUARD Study is an observational study looking at new blood and urine tests to find cancer early. Researchers are studying DNA methylation markers (changes in DNA that can be linked to cancer) to see if they can accurately detect cancer, including the 16 most deadly types, and pinpoint where the cancer might be in the body. They are also exploring if urine samples can be used for detection. This study aims to enroll 6150 participants aged 18 and older who have a confirmed cancer diagnosis. The main goals are to see if these tests can identify cancer and predict its location using blood and urine samples collected at the start of the study.

Study design
This is an observational study planning to enroll 6150 participants. It is not a treatment study, but rather focuses on collecting and analyzing samples.
What's involved
You would provide blood, urine, and/or residual tissue samples, and your medical records would be reviewed.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06304168

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

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~6,150 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall cancer (Y/N) - blood test
Measured over Baseline (samples collected at enrollment)
+5 more outcomes measured

Conditions

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

Explore related trials

Hematologic NeoplasmSolid Neoplasm

NCT06304168

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Eligibility criteria

Inclusion

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:
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

Exclusion

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
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

What this trial measures

  • Overall cancer (Y/N) - blood testBaseline (samples collected at enrollment)

    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.

  • Overall cancer (Y/N) - urine testBaseline (samples collected at enrollment)

    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.

  • Cancer specific site prediction - blood samples/MDMBaseline (samples collected at enrollment)

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

  • Cancer specific site prediction - urine samples/MDMBaseline (samples collected at enrollment)

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

  • Cancer specific site prediction - blood samples/RNABaseline (samples collected at enrollment)

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

  • Cancer specific site prediction - urine samples/RNABaseline (samples collected at enrollment)

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