John B. Kisiel, M.D.

The purpose of this study is to collect blood and stool samples to validate and improve the performance of stool and blood DNA markers for inflammatory bowel disease and colorectal neoplasia critical to the long-term goal of improving effectiveness of neoplasia detection in patients using non-invasive biomarkers to assist colonoscopy and radiographic screening. 

The primary aim of this study is to evaluate the distribution of marker levels determined by this multi-marker, multi-compartment blood DNA test approach across persons without known cancer or precancer.

The purpose of this study is to establish samples (blood and urine) to support the development of non-invasive tests for early detection of bladder cancer 

The purpose of this study is to assess the accuracy of DNA marker candidates (individually and in combination) assayed from urine and prostatic fluid (collected following digital prostate massage) for detection of prostate cancer.

The purpose of this study is to, in tissue, discover and validate DNA methylation markers (MDMs) for detection of invasive urothelial carcinoma of the bladder. In blood, to assess the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder. In urine, to explore the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder.  Diagnostic accuracy on urine can be compared with that on plasma using paired samples.

The purpose of this study is to validate candidate universal and site-specific methylated DNA markers (MDMs) in DNA extracted from formalin-fixed paraffin embedded primary tumor and control specimens.

The primary purpose of this study is to confirm the specificity of a multi-target stool DNA test, Cologuard, in an average risk population, ages 45-49.

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).

The primary purpose of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.

The purpose of this study is to assess for the circulating nucleic acid tumor markers dispersed in the various components of blood samples from patients with proven cancer.

The purpose of this study is to obtain clinically characterized, whole blood specimens from participants with new or suspected diagnosis of (cancer subjects) and from participants who do not have a diagnosis of cancer (healthy subjects) to develop and refine assays for cancer in the blood

The primary objective of this study is to obtain clinically characterized, whole blood specimens from cancer and healthy subjects to develop and refine assays for cancer in the blood.

The purpose of this study is to determine the performance of the Exact IBD-ACRN (inflammatory bowel disease-advanced colorectal neoplasia)surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease. Enrolled subjects must have undergone colonoscopy no more than 90 days prior to enrollment, will collect a stool sample for the surveillance test and then must undergo colonoscopy or surgical intervention within 120 days after enrollment.

The purpose of this study is to to determine the sensitivity and specificity of a second-generation multi-target stool DNA test (mt-sDNA 2.0) (Cologuard 2.0®, Exact Sciences Corporation) for colorectal neoplasia (CRN) in subjects with Lynch syndrome.

The purpose of the study is to see if the plasma assay of MDMs using optimized markers and analytically sensitive assays will detect early-stage esophageal cancer at high specificity.

The purpose of this study is to identify blood cell-specific DNA methylation and micro RNA markers in tissue and stool samples in patients wiht inflammatory bowel disease.

The research is being done to explore the potential impact of food ingestion on circulating DNA levels in the blood. 

The purpose of this study is to assess the long term clinical outcomes of patients who had a false positive stool DNA test for colorectal cancer.

The purpose of the study is to:

• Map and compare the neoplasia-associated epigenetic field in IBD-CRN, sporadic CRN and controls.  
• Measure sensitivity of DNA methylation for the detection of synchronous IBD-CRN as a complement or alternative to histologic diagnosis of dysplasia on random biopsies. 
• Measure the density and types of lymphocytes infiltrating IBD-CRN tumors, sporadic tumors and the epigenetic field. 

The purpose of this study is to assess Methylated DNA tumor markers distributed in blood samples of patients newly diagnosed with different types of lung cancer. The goal is to develop new blood screening tests that can identify the type and primary site of cancer.