Inflammatory Bowel Disease (IBD)OCEANIANCT01819766
Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease (IBD) and Primary Sclerosing Cholangitis (PSC), run by Exact Sciences Corporation at 26 sites in 2 countries.
Trial summary
This study aims to determine the performance of the Exact IBD-ACRN surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease (IBD). Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Primary Sclerosing Cholangitis (PSC), Colorectal Neoplasms
- How many people
- 440 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Mar 2013to Jan 2017
- 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 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have diagnosed IBD and are undergoing a colorectal cancer surveillance program. Also, have either a histopathological diagnosis of high grade dysplasia or colorectal cancer resulting from colonoscopy preceding enrollment or for whom a surveillance colonscopy is indicated.
Who may be able to join
- Male or female 18-84 years of age, inclusive.
- Diagnosis of IBD or a diagnosis of PSC with IBD prior to enrollment date of this study.
- Must be a candidate for a surveillance colonoscopy, with the intention of CRC/dysplasia surveillance, or a candidate for surgical intervention based on prior histological confirmation of HGD or CRC.
- Written informed consent document signed and dated by the subject or legally acceptable representative.
Who cannot join
- Any condition that in the opinion of the investigator should preclude participation in the study.
- A history of aerodigestive tract cancer.
- Prior colorectal resection, except ileocolic resection in Crohn's disease patients.
- IBD limited only to the rectum and without a concurrent PSC diagnosis.
- Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may be, introduced into the subject.
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States24 sites
Asheville Gastroeneterology Associates
Asheville, North Carolina, 28801
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Univeristy of North Carolina
Chapel Hill, North Carolina, 27599
MGG Group, Co. Inc./Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Medicine
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
NorthShore University Health System
Evanston, Illinois, 60201
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, 48334
Houston Methodist Hospital
Houston, Texas, 77030
UC San Diego Medical Center
La Jolla, California, 92093-0956
Advanced Research Institute
Logan, Utah, 84341
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Center for Digestive and Liver Diseases, Inc
Mexico, Missouri, 65265
University of Miami
Miami, Florida, 33136
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1610
Mount Sinai School of Medicine
New York, New York, 10029
Medical Research Associates of New York
New York, New York, 10075
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 1N4
Winnipeg Regional Health Authority-Health Sciences
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease: OCEANIA Study
This study aims to determine the performance of the Exact IBD-ACRN surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease (IBD). Patients with an IBD diagnosis for at least eight years or diagnosis of primary sclerosing cholangitis (PSC) and who are eligible for CRC screening are eligible to participate in this study. Enrolled subjects will collect a stool sample for the Exact IBD-ACRN surveillance test. Subjects must have undergone colonoscopy no more than 90 days prior to enrollment and will undergo colonoscopy or surgical intervention within 120 days of enrollment. Tissue diagnosis of CRC will be established by histopathologic examination.
Read the detailed description
This is a prospective, cross sectional, multi-center study to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test for detecting CRC alone and in combination with high grade dysplasia (HGD) and low grade dysplasia (LGD) associated with IBD and advanced adenoma in IBD patients with disease duration greater than 8 years or PSC diagnosis. Enrolled subjects will provide a single stool sample for the Exact IBD-ACRN surveillance test, no sooner than 7 days following their most recent pre-enrollment colonoscopy, within 30 days of enrollment and prior to initiating bowel prep for either the post-enrollment colonoscopy (surveillance or repeat), or surgical intervention. Stool samples will be tested using the Exact IBD-ACRN surveillance test and results compared to the colonoscopy and corresponding diagnostic histopathology results from biopsied, and any subsequently excised, lesions to establish sensitivity and specificity of the Exact IBD-ACRN surveillance test. All post-enrollment colonoscopies or surgical interventions must be performed within 60 days of enrollment.
The primary objective of this study is to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test for CRC in IBD patients with disease duration of at least eight years or diagnosis of PSC. Tissue diagnosis of CRC will be established by histopathology examination. The secondary objective is to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test to detect ACRN in IBD patients with disease duration of at least eight years or diagnosis of PSC.
Enrollment will continue until at least 35 CRC; 15 HGD and 315 negative subject samples have been obtained. There is no specific recruitment goal for IBD associated LGD or LGD associated with advanced adenoma (AA).
- Conditions
- Inflammatory Bowel Disease (IBD), Primary Sclerosing Cholangitis (PSC), Colorectal Neoplasms, Colorectal Cancer
- Keywords
- Cancer, Colorectal Cancer, Neoplasm, Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Inflammatory Bowel Disease, Primary Sclerosing Cholangitis
- Medical subject headings
- Inflammatory Bowel Diseases, Cholangitis, Sclerosing, Colorectal Neoplasms, Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site
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 |
|---|---|---|
| IBD or PSC | Subjects will be men and women, 18 to 84 years of age, inclusive, who are at increased risk of developing colorectal cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC.
With comparison to the colonoscopy results and histopathologic diagnosis of all lesions discovered during colonoscopy and either biopsied or removed during or subsequently removed after colonoscopy.
Measured: 9 months
Secondary outcomes (1)
Determine Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC and HGD.
Subjects with colonoscopic findings of CRC and/or high grade dysplasia (HGD) will be considered to have a positive outcome for composite CRC-HGD sensitivity calculations. Subjects with negative colonoscopic findings will be considered to have a negative outcome.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies 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
- Time perspective
- Cross-sectional
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Itzkowitz, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819766
- Sponsor's protocol ID
- Exact Sciences 2013-01
- Acronym
- OCEANIA
- Status last verified
- Aug 2016
- First submitted
- 25 Mar 2013
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease: OCEANIA Study
- ClinicalTrials.gov ID
- NCT01819766
- Acronym / sponsor ID
- OCEANIA / Exact Sciences 2013-01
- Conditions
- Inflammatory Bowel Disease (IBD), Primary Sclerosing Cholangitis (PSC), Colorectal Neoplasms, Colorectal Cancer
- Keywords
- Cancer, Colorectal Cancer, Neoplasm, Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 Mar 2013 (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.
This study aims to determine the performance of the Exact IBD-ACRN surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease (IBD). Patients with an IBD diagnosis for at least eight years or diagnosis of primary sclerosing cholangitis (PSC) and who are eligible for CRC screening are eligible to participate in this study. Enrolled subjects will collect a stool sample for the Exact IBD-ACRN surveillance test. Subjects must have undergone colonoscopy no more than 90 days prior to enrollment and will undergo colonoscopy or surgical intervention within 120 days of enrollment. Tissue diagnosis of CRC will be established by histopathologic examination.
Detailed description
This is a prospective, cross sectional, multi-center study to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test for detecting CRC alone and in combination with high grade dysplasia (HGD) and low grade dysplasia (LGD) associated with IBD and advanced adenoma in IBD patients with disease duration greater than 8 years or PSC diagnosis. Enrolled subjects will provide a single stool sample for the Exact IBD-ACRN surveillance test, no sooner than 7 days following their most recent pre-enrollment colonoscopy, within 30 days of enrollment and prior to initiating bowel prep for either the post-enrollment colonoscopy (surveillance or repeat), or surgical intervention. Stool samples will be tested using the Exact IBD-ACRN surveillance test and results compared to the colonoscopy and corresponding diagnostic histopathology results from biopsied, and any subsequently excised, lesions to establish sensitivity and specificity of the Exact IBD-ACRN surveillance test. All post-enrollment colonoscopies or surgical interventions must be performed within 60 days of enrollment.
The primary objective of this study is to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test for CRC in IBD patients with disease duration of at least eight years or diagnosis of PSC. Tissue diagnosis of CRC will be established by histopathology examination. The secondary objective is to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test to detect ACRN in IBD patients with disease duration of at least eight years or diagnosis of PSC.
Enrollment will continue until at least 35 CRC; 15 HGD and 315 negative subject samples have been obtained. There is no specific recruitment goal for IBD associated LGD or LGD associated with advanced adenoma (AA).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD or PSC | – | –Subjects will be men and women, 18 to 84 years of age, inclusive, who are at increased risk of developing colorectal cancer. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have diagnosed IBD and are undergoing a colorectal cancer surveillance program. Also, have either a histopathological diagnosis of high grade dysplasia or colorectal cancer resulting from colonoscopy preceding enrollment or for whom a surveillance colonscopy is indicated.
Key inclusion criteria (4 listed)
- Male or female 18-84 years of age, inclusive.
- Diagnosis of IBD or a diagnosis of PSC with IBD prior to enrollment date of this study.
- Must be a candidate for a surveillance colonoscopy, with the intention of CRC/dysplasia surveillance, or a candidate for surgical intervention based on prior histological confirmation of HGD or CRC.
- Written informed consent document signed and dated by the subject or legally acceptable representative.
Key exclusion criteria (5 listed)
- Any condition that in the opinion of the investigator should preclude participation in the study.
- A history of aerodigestive tract cancer.
- Prior colorectal resection, except ileocolic resection in Crohn's disease patients.
- IBD limited only to the rectum and without a concurrent PSC diagnosis.
- Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may be, introduced into the subject.
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
Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC.
Time frame: 9 months
With comparison to the colonoscopy results and histopathologic diagnosis of all lesions discovered during colonoscopy and either biopsied or removed during or subsequently removed after colonoscopy.
1 secondary outcome
Determine Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC and HGD.
Time frame: 9 months
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 17 Feb 2017.
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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.
Steven Itzkowitz, MD principal investigator
Icahn School of Medicine at Mount Sinai
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD) and Primary Sclerosing Cholangitis (PSC), run by Exact Sciences Corporation at 26 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 4 inclusion and 5 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. 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?
Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2017.