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

Mayo Clinic

Status: Enrolling

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06304168

NCI-2024-00954 (Registry Identifier)

19-000890 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 6,150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

6,150 participants in 1 patient group

Observational

Description:

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

Treatment:

Other: Non-Interventional Study