Hematopoietic and Lymphatic System NeoplasmDiagnostics and screeningGenetics
What this study is
This study explores the potential value of a new blood test approach for early detection of cancer.
What's being tested
- Non-Interventional Study
Intervention · OTHER
Non-interventional study
Study details
- Official title
- Validation of DNA Methylation Markers for the Universal and Site-Specific Guided Cancer Detection (the VANGUARD Study)
- Sponsor
- Mayo Clinic
- Conditions
- Hematopoietic and Lymphatic System Neoplasm · Malignant Solid Neoplasm
- Enrolling
- 6,150 people
- Starts
- 2019-05-13
- Est. completion
- 2028-05-15
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou 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 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
You can't join 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
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openMayo Clinic in Rochester
Rochester, Minnesota, United States
- Clinical Trials Referral Office · Contact855-776-0015mayocliniccancerstudies@mayo.edu
- John B. Kisiel, M.D. · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 19-000890
Principal investigator
John B. Kisiel, M.D.
Mayo Clinic in Rochester
Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.