PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening

Study Overview
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Brief Summary
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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.

Detailed Description
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The study is designed as a prospective, open enrollment clinical investigation involving multiple clinical study sites in the United States and Germany. Subjects will be competitively enrolled at multiple sites until at least 50 invasive colorectal adenocarcinoma cases identified by screening colonoscopy and verified by clinical and histopathological examination have been enrolled. The primary objective of the investigation is to evaluate and describe the clinical performance of the Septin 9 Biomarker for detecting the 50 individuals with invasive colorectal adenocarcinoma identified in this population representative of the US screening guideline eligible population. Secondary objectives will be to evaluate and describe performance characteristics of the biomarker in individuals with adenomatous polyps 10 mm or larger, flat lesion (s) or non-invasive adenocarcinoma. Collaborating sites will identify and contact patients scheduled for screening colonoscopy. These patients may be screened by the PI or designee to determine the patients' appropriateness for, and interest in, study participation. Study site personnel will meet with patients meeting eligibility guidelines and offer them participation. Patients interested in participation and who provide written informed consent will be enrolled as Subjects in the study.

Official Title
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PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: All eligible subjects will provide blood for SEPT9 biomarker testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent provided Capable of providing adequate health history Age 50 or older at time of colonoscopy (colorectal screening guideline eligible) Accessible for blood draw prior to start of bowel preparation for colonoscopy First large bowel endoscopy in lifetime Exclusion Criteria: Anorectal bleeding or hematochezia within last 6 months for which patient sought medical attention Known iron deficiency anemia in the last 6 months for which patient sought medical attention Previous history of colorectal polyps or CRC High risk for colorectal cancer (2 or more 10 relatives with CRC; 1 or more 10 relative(s) < 50 years with CRC; known HNPCC or FAP)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults > 50 Years Scheduled for Colonscopy<br>Average to increased risk adults older than 50 years without symptoms indicative of CRC and designated for colonoscopy. | Other: All eligible subjects will provide blood for SEPT9 biomarker testing<br>* A single blood sample per participant selected according to analysis plan is tested for evidence of methylation of a specific DNA sequence, SEPT9.<br>* Other names: DNA methylation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical/surgical diagnosis of invasive colorectal adenocarcinoma detected by optical colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification. |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, early detection, methylation, biomarker