PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening (PRESEPT)
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| ClinicalTrials.gov Identifier: NCT00855348 |
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Recruitment Status :
Completed
First Posted : March 4, 2009
Last Update Posted : August 4, 2014
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| Condition or disease | Intervention/treatment |
|---|---|
| Colorectal Cancer | Other: All eligible subjects will provide blood for SEPT9 biomarker testing |
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.
| Study Type : | Observational |
| Actual Enrollment : | 7929 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening |
| Study Start Date : | June 2008 |
| Actual Primary Completion Date : | January 2010 |
| Actual Study Completion Date : | April 2010 |
| Group/Cohort | Intervention/treatment |
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Adults > 50 Years Scheduled for Colonscopy
Average to increased risk adults older than 50 years without symptoms indicative of CRC and designated for colonoscopy.
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Other: All eligible subjects will provide blood for SEPT9 biomarker testing
A single blood sample per participant selected according to analysis plan is tested for evidence of methylation of a specific DNA sequence, SEPT9.
Other Names:
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- Clinical/surgical diagnosis of invasive colorectal adenocarcinoma detected by optical colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification. [ Time Frame: One Year ]
- 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. [ Time Frame: One Year ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855348
Show 23 study locations
| Principal Investigator: | Timothy R Church, Ph.D. | University of Minnesota | |
| Study Director: | Michael Wandell, PharmD. | Epigenomics, Inc | |
| Study Chair: | David F Ransohoff, MD | University of North Carolina |
| Responsible Party: | Timothy R. Church, Ph.D., University of Minnesota School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00855348 |
| Other Study ID Numbers: |
Epigenomics_SPR0006 |
| First Posted: | March 4, 2009 Key Record Dates |
| Last Update Posted: | August 4, 2014 |
| Last Verified: | August 2014 |
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colorectal cancer early detection methylation, biomarker |
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |