Inflammatory Bowel DiseaseNCT02503696
Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
An observational study of Inflammatory Bowel Disease and Colorectal Neoplasms, run by Exact Sciences Corporation at 29 sites in 2 countries.
Trial summary
The primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Inflammatory Bowel Disease, Colorectal Neoplasms, Digestive System Diseases
- What is being tested?
- Stool Collection Kit
- Type of treatment
- Medical device
- How many people
- 697 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Sep 2014to Jun 2016
- 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: Patients are at risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.
Who may be able to join
- Male or Female 18 - 84 years of age, inclusive, who have been diagnosed with IBD.
- Willing to provide a stool sample ≤120 but ≥7 days after a surveillance colonoscopy, which was negative for cancer/dysplasia.
- Written informed consent document signed and dated by the subject.
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.
- Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may have been, introduced into the subject.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States27 sites
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809
Boston Medical Center
Boston, Massachusetts, 02118
University of North Carolina
Chapel Hill, North Carolina, 27599
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
UC Health
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44195
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305
AGA Clinical Research Associates, LLC
Egg Harbor TWP, New Jersey, 08234
Medical Research Center of Conneticut
Hamden, Connecticut, 06518
Edward Hines Jr. VA Hospital
Hines, Illinois, 60141
Gastrointestinal Associates
Jackson, Mississippi, 39202
Kinston Medical Specialists, PA
Kinston, North Carolina, 28501
UC San Diego Medical Center
La Jolla, California, 92093
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53705
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Facey Medical Foundation
Mission Hills, California, 91345
Delta Research Partners
Monroe, Louisiana, 71201
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
HealthEast Midway Clinic
Saint Paul, Minnesota, 55104
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103
Canada2 sites
University of Calgary - Division of Gastroenterology
Calgary, Alberta, T2N1N4
Winnipeg Regional Health Authority- Health Sciences
Winnipeg, Manitoba, R3A 1R9
About this study
The primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).
- Conditions
- Inflammatory Bowel Disease, Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer
- Being tested
- Stool Collection Kit
- Keywords
- Inflammatory Bowel Disease, 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, Rectal Diseases
- Medical subject headings
- Inflammatory Bowel Diseases, Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool Collection KitDevice
Stool Collection Kit.
| Study group | Role | What they receive |
|---|---|---|
| IBD | Subjects will be men and women, 18-84 years of age, inclusive, who have been diagnosed with IBD. Each with a screening colonoscopy resulting in normal findings. Receives: Device: Stool Collection Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the Exact CRC diagnostic screening test.
The primary endpoint is point estimates of the sensitivity of the diagnostic test for detection of colorectal cancer in IBD patients.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 697 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Graham Lidgard, PhD, Study chair, Exact Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503696
- Sponsor's protocol ID
- 2014-05
- Status last verified
- Aug 2016
- First submitted
- 17 Jul 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT02503696
- Acronym / sponsor ID
- 2014-05
- Conditions
- Inflammatory Bowel Disease, Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer
- Keywords
- Inflammatory Bowel Disease, Cancer, Colorectal Cancer, Neoplasm, Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 697 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Jul 2015 (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 primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD | – | Device: Stool Collection KitSubjects will be men and women, 18-84 years of age, inclusive, who have been diagnosed with IBD. Each with a screening colonoscopy resulting in normal findings. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are at risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.
Key inclusion criteria (3 listed)
- Male or Female 18 - 84 years of age, inclusive, who have been diagnosed with IBD.
- Willing to provide a stool sample ≤120 but ≥7 days after a surveillance colonoscopy, which was negative for cancer/dysplasia.
- Written informed consent document signed and dated by the subject.
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.
- Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may have been, 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool Collection KitStool Collection Kit. | Device | IBD |
Primary outcome
Sensitivity and Specificity of the Exact CRC diagnostic screening test.
Time frame: 15 months
The primary endpoint is point estimates of the sensitivity of the diagnostic test for detection of colorectal cancer in IBD patients.
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 10 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Graham Lidgard, PhD study chair
Exact Sciences
29 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 and Colorectal Neoplasms, run by Exact Sciences Corporation at 29 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 3 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 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 CRC diagnostic screening test. (time frame: 15 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 10 Aug 2016.