Image

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

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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

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

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 details

Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

NCT06304168

Mayo Clinic

19 March 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.