Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study
This study explores the potential value of a new blood test approach for early detection of cancer.
- EligibilityCriteria: 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 - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Cancer and control patients who will be seen or treated at Mayo clinic. - SamplingMethod: Non-Probability Sample