Colorectal CancerPRESEPTNCT00855348
PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening
An observational study of Colorectal Cancer, run by Epigenomics, Inc at 23 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- All eligible subjects will provide blood for SEPT9 biomarker testing
- How many people
- 7,929 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Jun 2008to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be conducted in Subjects scheduled for screening colonoscopy according to current U.S. CRC screening guidelines.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States20 sites
Asheville Gastroenterology Associates PA
Asheville, North Carolina, 28801
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30134
Northwest Gastroenterology Associates
Bellevue, Washington, 98008
Digestive Care
Boca Raton, Florida, 33486
Medical University of South Carolina Digestive Disease Center
Charleston, South Carolina, 29425
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Heartland Medical Research, Inc.
Clive, Iowa, 50325
Gastroenterology Center of the MidSouth
Germantown, Tennessee, 38138
Jackson Gastrointestinal Associates
Jackson, Mississippi, 39202
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, 17604
University of Louisville
Louisville, Kentucky, 40202
GI Care Center
Miami, Florida, 33173
Minnesota Gastroenterology
Minneapolis, Minnesota, 55455
Southern Gastroenterology Associates
New Bern, North Carolina, 28562
The Portland Clinic
Portland, Oregon, 97205
Northwest Gastroenterology Clinic
Portland, Oregon, 97210
The Oregon Clinic
Portland, Oregon, 97220
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, 61107
Tacoma Digestive Disease Research Center
Tacoma, Washington, 98405
Digestive Health Specialists
Winston-Salem, North Carolina, 27103
Germany3 sites
Berlin Private-Practice Gastroenterology Working Group
Berlin
University of Hamburg-Eppendorf
Hamburg, 20246
Technical University of Munich
Munich
About this study
Official title: PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Being tested
- All eligible subjects will provide blood for SEPT9 biomarker testing
- Keywords
- colorectal cancer, early detection, methylation, biomarker
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All eligible subjects will provide blood for SEPT9 biomarker testingOther
Also called biomarker, blood, colorectal cancer, DNA methylation
A single blood sample per participant selected according to analysis plan is tested for evidence of methylation of a specific DNA sequence, SEPT9.
| Study group | Role | What they receive |
|---|---|---|
| Adults > 50 Years Scheduled for Colonscopy | Average to increased risk adults older than 50 years without symptoms indicative of CRC and designated for colonoscopy. Receives: Other: All eligible subjects will provide blood for SEPT9 biomarker testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical/surgical diagnosis of invasive colorectal adenocarcinoma detected by optical colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification.
Measured: One Year
Secondary outcomes (1)
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.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,929 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epigenomics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Timothy R Church, Ph.D., Principal investigator, University of MinnesotaMichael Wandell, PharmD., Study director, Epigenomics, IncDavid F Ransohoff, MD, Study chair, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855348
- Sponsor's protocol ID
- Epigenomics_SPR0006
- Acronym
- PRESEPT
- Status last verified
- Aug 2014
- First submitted
- 4 Feb 2009
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Payne 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.
PubMed 24333512Church 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.
PubMed 23408352
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT00855348
- Acronym / sponsor ID
- PRESEPT / Epigenomics_SPR0006
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, early detection, methylation, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,929 participants (actual)
- Lead sponsor
- Epigenomics, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults > 50 Years Scheduled for Colonscopy | – | Other: All eligible subjects will provide blood for SEPT9 biomarker testingAverage to increased risk adults older than 50 years without symptoms indicative of CRC and designated for colonoscopy. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in Subjects scheduled for screening colonoscopy according to current U.S. CRC screening guidelines.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All eligible subjects will provide blood for SEPT9 biomarker testingAlso: biomarker, blood, colorectal cancer, DNA methylationA single blood sample per participant selected according to analysis plan is tested for evidence of methylation of a specific DNA sequence, SEPT9. | Other | Adults > 50 Years Scheduled for Colonscopy |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
- Derived from this study: PubMed 24333512Payne 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.
- Derived from this study: PubMed 23408352Church 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy R Church, Ph.D. principal investigator
University of Minnesota
Michael Wandell, PharmD. study director
Epigenomics, Inc
David F Ransohoff, MD study chair
University of North Carolina
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Epigenomics, Inc at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855348, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2014.