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

NCT06304168 | Recruiting

• 2 other identifiers: 19-000890NCI-2024-00954
• Study Type: observational
• Target: 6,150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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:

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• John B. Kisiel, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 12, 2024
• Study Start: May 13, 2019
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)