PRESEPT Study: Prospective Evaluation of SEPT9 Performance for Colorectal Screening
Summary: The purpose of this study is to collect blood specimens and clinical data from screening guideline eligible individuals designated by their physician to receive a screening colonoscopy, and to evaluate the performance of a colorectal cancer-specific DNA methylation biomarker for detection of colorectal cancer in this cohort. Based on the outcome of the colonoscopy, polypectomy, biopsy and surgical tissue histopathology, the clinical utility of Septin 9 as colorectal cancer screening test will be evaluated.
| HR#: |
18525 |
| PRINCIPAL INVESTIGATOR: |
Joseph Romagnuolo, , MD, FRCPC, FASGE, MScEpid |
| SPONSOR: |
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| TARGET ENROLLMENT: |
535 |
| DISEASE TYPE: |
Other |
| BODY LOCATION(S): |
Large Intestine, |
| PRIMARY OBJECTIVE: |
To evaluate and validate the clinical performance of the SEPT9 Assay for detecting colorectal adenocarcinoma (Stage I-IV) in screening guideline-eligible individuals scheduled for screening colonoscopy |
| SECONDARY OBJECTIVE(S): |
Detection of adenomatous polyp(s) equal to or greater than 10 mm, flat lesion (s) or non-invasive adenocarcinoma by colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification will also be described |
| INCLUSION CRITERIA: |
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| Informed consent provided. |
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| Capable of providing adequate health history. |
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| Age 50 or older at time of colonoscopy (colorectal screening guideline eligible). |
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| Accessible for blood draw prior to start of bowel preparation for colonoscopy. |
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| First large bowel endoscopy in lifetime. |
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| EXCLUSION CRITERIA: |
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1
| Anorectal bleeding or hematochezia within last 6 months for which patient sought medical attention. |
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2
| Known iron deficiency anemia in the last 6 months for which patient sought medical attention. |
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3
| Previous history of colorectal polyps or CRC. |
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| High risk for colorectal cancer (2 or more primary relatives with CRC; 1 or more primary relative(s) <50 years with CRC, known HNPCC or FAP). |
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| TREATMENT GROUPS: |
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| LENGTH OF STUDY: |
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| CONTACTS: |
- Rebekah Whichard, , BA, CCRC (Primary Study Coordinator)
(843) 876-7233 or richreb@musc.edu
- Kyle Orrell, MSHP (DDC Research Program Manager)
843-876-4303 or orrell@musc.edu
- Joseph Romagnuolo, , MD, FRCPC, FASGE, MScEpid (Principal Investigator)
(843) 876-4261 or romagnuo@musc.edu
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