Validation of blood and urine tests for early cancer detection
Validation of DNA Methylation Markers for the Universal and Site-Specific Guided Cancer Detection (the VANGUARD Study)
This study is testing if blood and urine tests can help find some of the deadliest cancers earlier in people who have them compared to those who don’t.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06304168 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate DNA methylation markers (MDMs) for the early detection of various lethal cancers using blood and urine samples. It involves collecting tissue, blood, and urine samples from patients with confirmed cancer diagnoses and comparing them to control samples from individuals without cancer. The study will assess the feasibility of using these non-invasive biological mediums to detect the top 16 most lethal human cancers, potentially leading to earlier diagnosis and treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with biopsy-confirmed diagnoses of hematopoietic and lymphatic system neoplasms or malignant solid neoplasms.
Not a fit: Patients without a confirmed cancer diagnosis or those with non-target histologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for early cancer detection, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using DNA methylation markers for cancer detection, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: John B. Kisiel, M.D. — Mayo Clinic in Rochester
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.