Recruiting

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

Sponsor:

Mayo Clinic

Code:

NCT06304168

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Non-Interventional Study

Study Details

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

Study ID

NCT06304168

Start date

May 13, 2019

Status verified date

Aug, 2026

Completion date

May 15, 2028

Anticipated

Primary completion date

May 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 documented diagnosis of cancer within 1 year following blood collections
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

Controls:

Patient has known cancer prior to current sample acquisition (not including basal cell or squamous cell skin cancers) (if patient has not been seen or if information is not available, the patient is still eligible)
Cases:

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 an intervention to completely remove current target pathology
The current target pathology is a recurrence
Patient has had a biopsy to the target organ and/or lesion within 3 days before blood collection
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

Study Design

Enrollment

6150 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

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

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

Overall cancer (Y/N) - blood test [ Time Frame: Baseline (samples collected at enrollment) ]
Overall cancer (Y/N) - urine test [ Time Frame: Baseline (samples collected at enrollment) ]
Cancer specific site prediction - blood samples/MDM [ Time Frame: Baseline (samples collected at enrollment) ]
Cancer specific site prediction - urine samples/MDM [ Time Frame: Baseline (samples collected at enrollment) ]
Cancer specific site prediction - blood samples/RNA [ Time Frame: Baseline (samples collected at enrollment) ]
Cancer specific site prediction - urine samples/RNA [ Time Frame: Baseline (samples collected at enrollment) ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

John B. Kisiel, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-20.