NCT06304168 Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study
| NCT ID | NCT06304168 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Hematopoietic and Lymphatic System Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,150 participants |
| Start Date | 2019-05-13 |
| Primary Completion | 2028-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,150 participants in total. It began in 2019-05-13 with a primary completion date of 2028-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study explores the potential value of a new blood test approach for early detection of cancer.
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
Contact & Investigator
John B. Kisiel, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06304168 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematopoietic and Lymphatic System Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06304168 currently recruiting?
Yes, NCT06304168 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT06304168 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06304168 clinical trial?
NCT06304168 is sponsored by Mayo Clinic. The principal investigator is John B. Kisiel, M.D. at Mayo Clinic in Rochester. The trial plans to enroll 6,150 participants.