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Trial Contacts

Endocytoscopy Primary Investigator: Anna Buchner, MD
Research Coordinator: Julie Starr
demarshm@mail.med.upenn.edu

Epi proColon Primary Investigator: Bryson Katona, MD, PhD
Research Coordinator: Justine Jou
Justine.Jou@pennmedicine.upenn.edu
215-360-0833

Research Coordinator: Alice Alderson
Alice.Alderson@pennmedicine.upenn.edu
215-360-0905

Studies

The Role of in Vivo Real Time Endocytoscopy in Diagnosing Colorectal Neoplasia

Endocytoscopy and Colorectal Neoplasia

This is a pilot study to evaluate the role of endocytoscopy in classifying colorectal polyps in vivo. The primary outcomes are to determine the key endocytoscopy image features of neoplastic and non-neoplastic colorectal polyps. The target population includes adult subjects undergoing screening and surveillance colonoscopies.

Epi proColon

Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development

Epigenomics has developed Epi proColon, a blood based screening test for colorectal cancer that has been approved by the U.S. Food and Drug Administration (FDA). In this study we are testing investigational colorectal cancer markers and methods to make improvements to the approved test, and to develop other investigational tests. While the Epi proColon test is approved the FDA, the investigational markers, methods and additional tests are not.

Study is recruiting subjects with newly diagnosed colorectal cancer as well as patients undergoing a screening endoscopy.

Participation in the study will require researchers to collect your basic information and a blood sample.

Criteria

Inclusion Criteria: Colorectal Cancer
Willing and able to sign an Informed Consent and adhere to study requirements.
Subjects with colorectal cancer preferably detected by screening (any guideline recommended modality)
Colonoscopy diagnosis of colorectal cancer (CRC)
Blood sampling a minimum of seven days after surgery of CRC and be accompanied by a complete final pathology report.

Inclusion Criteria: Screening Colonoscopy
Willing and able to sign an Informed Consent and adhere to study requirements
Eligible for colorectal cancer screening colonoscopy
45-84 years of age at blood sampling
Able to provide blood sample within up to two weeks prior to bowel prep and colonoscopy

Exclusion Criteria: Colorectal Cancer
Subject with curative biopsy during colonoscopy
Current neoadjuvant treatment
Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer
Known infection with HIV, HBV, or HCV

Exclusion Criteria: Screening Colonoscopy
Previous personal history of CRC, adenomatous polyps>10mm or sessile serrated adenomas
Familial risk for colorectal cancer (one or more 1stdegree relatives with CRC; known HNPCC or FAP)
History of inflammatory bowel disease
Current neoadjuvant treatment
Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer
Infection with HIV, HBV, or HCV

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