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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVES:

I. 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 the top 16 most lethal human 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.

• Study Type: Observational
• Enrollment (Estimated): 6150

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: John B. Kisiel, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Cancer and control patients who will be seen or treated at Mayo clinic.

Description

Inclusion Criteria:

• 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 diagnosis of the target histology

• 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 Criteria:

• 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

  • Cases and Controls:

    • 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 a biopsy to the target organ and/or lesion within 3 days before blood collection

  • Cases:

    • Patient has had an intervention to completely remove current target pathology
    • The current target pathology is a recurrence
    • 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/DCIS

• 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
    • Patient has multi-centric/multi-focal breast cancer with differing genetic profiles [estrogen receptor (ER)/human epidermal growth factor receptor 2 (HER2)/progesterone receptor (PR)] status differ; if multiple masses are present and not all are tested then exclude patient)
    • Patient has bilateral breast cancer/DCIS

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients undergo blood, urine, and/or residual tissue sample collection and have their medical records reviewed on study.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (samples collected at enrollment)
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.	Baseline (samples collected at enrollment)
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.	Baseline (samples collected at enrollment)
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.	Baseline (samples collected at enrollment)
Cancer specific site prediction - blood samples/RNA	Blood samples will be assayed for ribonucleic acid (RNA) to identify individual organ sites of primary tumors.	Baseline (samples collected at enrollment)
Cancer specific site prediction - urine samples/RNA	Urine samples will be assayed for ribonucleic acid (RNA) to identify individual organ sites of primary tumors.	Baseline (samples collected at enrollment)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: John B. Kisiel, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 19-000890 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2024-00954 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No