Clinical trial · Observational
PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening
PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| All eligible subjects will provide blood for SEPT9 biomarker testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults > 50 Years Scheduled for Colonscopy
- description
- Average to increased risk adults older than 50 years without symptoms indicative of CRC and designated for colonoscopy.
- interventionNames
- Other: All eligible subjects will provide blood for SEPT9 biomarker testing
Primary outcomes (1)
- measure
- Clinical/surgical diagnosis of invasive colorectal adenocarcinoma detected by optical colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification.
- timeFrame
- One Year
Secondary outcomes (1)
- measure
- 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.
- timeFrame
- One Year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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)
References
Publications (2)
- DERIVEDPayne SR, Church TR, Wandell M, Rosch T, Osborn N, Snover D, Day RW, Ransohoff DF, Rex DK. Endoscopic detection of proximal serrated lesions and pathologic identification of sessile serrated adenomas/polyps vary on the basis of center. Clin Gastroenterol Hepatol. 2014 Jul;12(7):1119-26. doi: 10.1016/j.cgh.2013.11.034. Epub 2013 Dec 10. PMID 24333512
- DERIVEDChurch TR, Wandell M, Lofton-Day C, Mongin SJ, Burger M, Payne SR, Castanos-Velez E, Blumenstein BA, Rosch T, Osborn N, Snover D, Day RW, Ransohoff DF; PRESEPT Clinical Study Steering Committee, Investigators and Study Team. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. Gut. 2014 Feb;63(2):317-25. doi: 10.1136/gutjnl-2012-304149. Epub 2013 Feb 13. PMID 23408352