Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
This study explores the potential value of a new blood test approach for early detection of cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aim 1 Tissue
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
Disqualifiers
Aim 1 Tissue
Patient has had any transplants prior to tissue collection
Patient has received chemotherapy class drugs within 5 years prior to tissue collection
Patient has had radiation to the current target lesion prior to tissue collection
Trial population
Cancer and control patients who will be seen or treated at Mayo clinic.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
6,150 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (samples collected at enrollment)2
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.
Time frame
Baseline (samples collected at enrollment)3
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.
Time frame
Baseline (samples collected at enrollment)4
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.
Time frame
Baseline (samples collected at enrollment)Sponsors and contacts
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Source ClinicalTrials.gov