Overview
This study explores the potential value of a new blood test approach for early detection of cancer.
Description
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
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
- Cases:
- 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
- Cases:
- 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
- Cases:
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)
- Cases and Controls:
- 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
- Cases and Controls:
- 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