Clinical trial NCT06304168: Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study
Official title: Validation of DNA Methylation Markers for the Universal and Site-Specific Guided Cancer Detection (the VANGUARD Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 6150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer and control patients who will be seen or treated at Mayo clinic.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall cancer (Y/N) - blood test
timeFrame: Baseline (samples collected at enrollment)
measure: Overall cancer (Y/N) - urine test
timeFrame: Baseline (samples collected at enrollment)
measure: Cancer specific site prediction - blood samples/MDM
timeFrame: Baseline (samples collected at enrollment)
measure: Cancer specific site prediction - urine samples/MDM
timeFrame: Baseline (samples collected at enrollment)
measure: Cancer specific site prediction - blood samples/RNA
timeFrame: Baseline (samples collected at enrollment)
measure: Cancer specific site prediction - urine samples/RNA
timeFrame: Baseline (samples collected at enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: John B. Kisiel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: