validation of dna methylation markers for universal and site-specific guided cancer detection, vanguard study

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Summary: this study explores the potential value of a new blood test approach for early detection of cancer.

primary objectives: i. validate candidate universal and site-specific mdms in dna extracted from formalin-fixed paraffin embedded primary tumor and control specimens. ii. test mdm-based models for detection of the top 16 most lethal human cancers using a non-invasive biological medium, specifically blood. iii. assess feasibility for detection of cancers using urine samples to assay mdms, rna or protein in cell free or extra-cellular vesicles; patients may be the same or unique individuals from aim 1 and 2. outline: this is an observational study. patients undergo blood, urine, and/or residual tissue sample collection and have their medical records reviewed on study.

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