Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingObservational

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

NCT ID: NCT06304168Sponsor: Mayo ClinicLast updated: 2026-03-03

Summary

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

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.

Arms & interventions

  • OtherNon-Interventional Study

    Non-interventional study

Outcome measures

Primary

  • 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline (samples collected at enrollment)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
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 locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting
Clinical Trials Referral Office · Contact
John B. Kisiel, M.D. · Principal Investigator
Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study | Cancerify