Colorectal CancerNCT01580540
Head to Head Study Epi proColon and FIT
An observational study of Colorectal Cancer, run by Epigenomics, Inc at 70 sites in 2 countries.
Trial summary
The study aims to show non-inferiority in the clinical performance of the investigational assay, Epi proColon, to FIT using matched blood and stool specimens from screening-guideline eligible subjects. Read more about this study
- Who is it for?
- Ages 50 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 336 participants
- Where
- 70 sitesin 2 countries
- Study dates
- Mar 2012to Nov 2012
- 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 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects are recruited from gastroenterology clinics and surgical centers in the United States.
Who may be able to join
- Group A
- Willing and able to sign an informed consent and adhere to study requirements
- 50 - 84 years of age at blood and stool sampling
- Colonoscopic diagnosis of colorectal carcinoma
- Colonoscopy within 6 months before inclusion into study
- Blood and stool sampling a minimum of 10 days after colonoscopy and before resection surgery
Show all 10Show fewer
- Group B
- Willing and able to sign an informed consent and adhere to study requirements
- 50 - 84 years of age at blood and stool sampling
- Able to provide blood and stool sample prior to bowel prep and colonoscopy
Who cannot join
- Group A
- Subject with curative biopsy during colonoscopy
- Group A and B
- Previous personal history of CRC or previous colonocopy resulting in a recommendation to repeat colonoscopy at an interval less than 10 years
- Neoadjuvant treatment
- Familial risk for colorectal cancer
Show all 12Show fewer
- History of inflammatory bowel disease
- Acute or chronic gastritis
- Current diagnosis of any other cancer
- Overt rectal bleeding or bleeding hemorrhoids
- Known infection with HIV, HBV, or HCV
- Subject concurrently receiving intravenous fluid at the time of the sample collection
Trial locations and contacts
70 sites in 2 countries.
70 sites in 2 countries
United States69 sites
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801
PMI Research
Atlanta, Georgia, 30312
Bend Memorial Clinic
Bend, Oregon, 97701
Binghampton Gastroenterology Associates
Binghampton, New York, 13903
Achieve Clinical Research LLC
Birmingham, Alabama, 35216
Legacy Pharma Research
Bismarck, North Dakota, 58501
Zasa Clinical Research
Boyton Beach, Florida, 33472
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606
Commonwealth Clinical Trials
Brockton, Massachusetts, 02302
Life Medi-research and Management
Brooklyn, New York, 11206
Independent Clinical Research, LLC
Carrolton, Texas, 75010
Greater Arizona Gastroenterology Associates
Casa Grande, Arizona, 85122
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, 28207
Carolina Digestive Health Associates
Charlotte, North Carolina, 28226
ClinSearch, LLC
Chattanooga, Tennessee, 37421
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815
Gastroenterology Research Consultants of Greater Cincinnati
Cincinnati, Ohio, 45242
Bassett Healthcare Center
Cooperstown, New York, 13326
Clinical Research of South Florida
Coral Gables, Florida, 33134
Clinical Trials of America, Inc.
Eugene, Oregon, 97401
Lillestol Research, LLC
Fargo, North Dakota, 58103
Center for Gastrointestinal Disorders
Hollywood, Florida, 33021
Saint Francis Cancer Care Center
Indianapolis, Indiana, 46237
Research Medical Center
Kansas City, Missouri, 64132
Gastroenterology Associates
Kingsport, Tennessee, 37660
Atlantic Medical Group
Kinston, North Carolina, 28501
South Orange County Surgical Medical Group
Laguna Hills, California, 92653
Healthcare Partners Medical Group
Los Angeles, California, 90015
Dean Foundation Medical Research
Madison, Wisconsin, 53715
University of Wisconsin
Madison, Wisconsin, 53792
Trover Center for Clinical Studies
Madisonville, Kentucky, 42431
New Orleans Research Institute
Metairie, Louisiana, 70006
Palm Springs Research Institute, Inc
Miami, Florida, 33126
United Clinical Research, Corp.
Miami, Florida, 33155
Advance Medical Research Service Corp.
Miami, Florida, 33165
Middlesex Hospital Cancer Center
Middletown, Connecticut, 06457
Futura Research, Inc.
Montebello, California, 90640
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Southern California Research Institute Medical Group, Inc.
Murrieta, California, 92502
West Gastroenterology Medical Group
Murrieta, California, 92502
Physicians Regional Medical Center
Naples, Florida, 34119
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Mid Hudson Medical Research, PLLC
New Windsor, New York, 12553
New York Gastroenterology Associates, LLP
New York, New York, 10075
Montefiore - Einstein Cancer Care Center
New York, New York, 10641
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
Detroit Clinical Research Center
Novi, Michigan, 48377
Diverse Research Solutions, LLC
Oxnard, California, 93030
Advance Medical Research Group
Palm Harbor, Florida
Accord Clinical Research, LLC
Port Orange, Florida, 32129
Inland Gastroenterology Medical Associates, Inc.
Redlands, California, 92374
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, 61107
Beaumont Hospital
Royal Oak, Michigan, 48073
Salt Lake Research
Salt Lake City, Utah, 84107
Santa Monica Research Institute
Santa Monica, California, 90404
Bux-Mont Gastroenterology Associates
Sellersville, Pennsylvania, 18960
Louisiana Research Center
Shreveport, Louisiana, 71103
Digestive Associates of Houston
Spring, Texas, 77386
Spring Gastroenterology
Spring, Texas, 77386
Springfield Clinic
Springfield, Illinois, 62703
Multicare Health Systems, Medical Oncology
Tacoma, Washington, 98405
Stedman Clinical Trials, LLC
Tampa, Florida, 33613
Troy Gastroenterology PC Center for Digestive Health
Troy, Michigan, 48098
Visions Clinical Research
Tucson, Arizona, 85712
Innovative Clinical Research Institute
Whittier, California, 90603
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103
Piedmont Medical Research Associates, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: Comparison of the Performance of the Epi proColon and Fecal ImmunochemicalTest Post Colonoscopy in Subjects With Colorectal Cancer and Pre Colonoscopy in Subjects From a Guideline-Eligible Screening Population
The study aims to show non-inferiority in the clinical performance of the investigational assay, Epi proColon, to FIT using matched blood and stool specimens from screening-guideline eligible subjects.
Read the detailed description
There is strong evidence supporting the use of FOBT in CRC screening, with the earliest randomized controlled trials demonstrating a reduction in CRC incidence and mortality from CRC screening. Despite the implementation and incremental improvements in gFOBT- and FIT-based tests, they continue to represent a small percentage of CRC screening and currently remain largely the province of large, integrated healthcare delivery systems. Reasons for the limited adoption of stool-based testing are complicated, but include lack of physician recommendation, patient preferences, and cultural barriers.
Availability of a blood-based test may overcome the adoption challenges presently facing stool-based CRC screening and facilitate better compliance with CRC screening guidelines. However, there are currently no FDA-approved in vitro diagnostic tests for detection of CRC in a blood sample. As such, a high through-put blood-based test with performance characteristics similar to fecal testing could satisfy this clinical need.
This study is designed to prospectively collect matched blood and stool specimens and clinical data from screening guideline-eligible subjects found to have invasive colorectal cancer (CRC) at colonoscopy, i.e. AJCC/UICC stages I, II, III, and IV, with collection of specimens and testing after colonoscopy and from screening guideline-eligible subjects with blood and stool specimens collected before colonoscopy. A completed subject will have a FIT result, an Epi proColon result, and a medical diagnosis/colonoscopy determined clinical status (CRC, non-CRC). Demographic and baseline covariates will be reported for each individual.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A, subjects with colorectal cancer | Subjects between ages 50 and 84 identified to have CRC. Blood and stool specimens are collected and tested after colonoscopy and prior to surgery or other interventions. | |
| Group B, subjects without CRC | Subjects between ages 50 and 84 who provide stool and blood specimens prior to colonoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of Epi proColon test result compared to FIT result using a 95% confidence interval for difference in sensitivities and differences in specificities below a strictly defined margin.
Measured: At completion of testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Case-control
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epigenomics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juergen Beck, MD, Principal investigator, Epigenomics, IncNeil Mucci, Study director, Epigenomics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580540
- Sponsor's protocol ID
- Epigenomics-SPR 0022
- Status last verified
- Jul 2014
- First submitted
- 17 Apr 2012
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.
PubMed 24901436
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Performance of the Epi proColon and Fecal ImmunochemicalTest Post Colonoscopy in Subjects With Colorectal Cancer and Pre Colonoscopy in Subjects From a Guideline-Eligible Screening Population
- ClinicalTrials.gov ID
- NCT01580540
- Acronym / sponsor ID
- Epigenomics-SPR 0022
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Epigenomics, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 19 Apr 2012 (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 study aims to show non-inferiority in the clinical performance of the investigational assay, Epi proColon, to FIT using matched blood and stool specimens from screening-guideline eligible subjects.
Detailed description
There is strong evidence supporting the use of FOBT in CRC screening, with the earliest randomized controlled trials demonstrating a reduction in CRC incidence and mortality from CRC screening. Despite the implementation and incremental improvements in gFOBT- and FIT-based tests, they continue to represent a small percentage of CRC screening and currently remain largely the province of large, integrated healthcare delivery systems. Reasons for the limited adoption of stool-based testing are complicated, but include lack of physician recommendation, patient preferences, and cultural barriers.
Availability of a blood-based test may overcome the adoption challenges presently facing stool-based CRC screening and facilitate better compliance with CRC screening guidelines. However, there are currently no FDA-approved in vitro diagnostic tests for detection of CRC in a blood sample. As such, a high through-put blood-based test with performance characteristics similar to fecal testing could satisfy this clinical need.
This study is designed to prospectively collect matched blood and stool specimens and clinical data from screening guideline-eligible subjects found to have invasive colorectal cancer (CRC) at colonoscopy, i.e. AJCC/UICC stages I, II, III, and IV, with collection of specimens and testing after colonoscopy and from screening guideline-eligible subjects with blood and stool specimens collected before colonoscopy. A completed subject will have a FIT result, an Epi proColon result, and a medical diagnosis/colonoscopy determined clinical status (CRC, non-CRC). Demographic and baseline covariates will be reported for each individual.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, subjects with colorectal cancer | – | –Subjects between ages 50 and 84 identified to have CRC. Blood and stool specimens are collected and tested after colonoscopy and prior to surgery or other interventions. |
| Group B, subjects without CRC | – | –Subjects between ages 50 and 84 who provide stool and blood specimens prior to colonoscopy. |
Who may qualify
- Ages
- 50 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are recruited from gastroenterology clinics and surgical centers in the United States.
Key inclusion criteria (10 listed)
- Group A
- Willing and able to sign an informed consent and adhere to study requirements
- 50 - 84 years of age at blood and stool sampling
- Colonoscopic diagnosis of colorectal carcinoma
- Colonoscopy within 6 months before inclusion into study
Key exclusion criteria (12 listed)
- Group A
- Subject with curative biopsy during colonoscopy
- Group A and B
- Previous personal history of CRC or previous colonocopy resulting in a recommendation to repeat colonoscopy at an interval less than 10 years
- Neoadjuvant treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Non-inferiority of Epi proColon test result compared to FIT result using a 95% confidence interval for difference in sensitivities and differences in specificities below a strictly defined margin.
Time frame: At completion of testing.
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 2015.
- Derived from this study: PubMed 24901436Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.
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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.
Juergen Beck, MD principal investigator
Epigenomics, Inc
Neil Mucci study director
Epigenomics, Inc
70 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 70 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 10 inclusion and 12 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 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Puerto Rico. 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?
Non-inferiority of Epi proColon test result compared to FIT result using a 95% confidence interval for difference in sensitivities and differences in specificities below a strictly defined margin. (time frame: At completion of testing.). 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 NCT01580540, which also lists 1 linked publication.
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 2015.