Crohn DiseasePREDIPOSTOPNCT02878395
Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases
An observational study of Crohn Disease, run by Central Hospital, Nancy, France.
Trial summary
The purpose is to search for enterocyte-specific or non-specific molecular signature of post-operating recurrence of Crohn's disease in transcriptome (measurement of gene expression through number of mRNA copies transcribed for each gene) and in methylome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Ileocolic resection
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Crohn's disease needing an ileocolic resection at CHRU Nancy.
Who may be able to join
- Patient with inflammatory bowel disease diagnosis based on clinical (abdominal pain, diarrhea and/or dysenteric syndrome, mostly muco-hemorrhagic, perianal injury, with sometimes general signs and /or systemic manifestations ), biological (inflammatory syndrome, deficiencies…), radiological (entero-MRI), endoscopic (presence of granulomatous lesions) and/or histological (epithelioid and giant cellular granuloma) data
- Patient undergoing ileocolic resection
- Patient affiliated to French social security
Who cannot join
- Patient refusing sampling
- Patient with undetermined colitis
- Patient with non-confirmed diagnosis of inflammatory bowel disease
- Patient with inflammatory bowel disease not undergoing ileocolic resection
Trial locations and contacts
No sites are listed yet.
Adeline GERMAIN contact
About this study
Official title: Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases: Prediction of Post-operating Natural History of Crohn's Disease
The purpose is to search for enterocyte-specific or non-specific molecular signature of post-operating recurrence of Crohn's disease in transcriptome (measurement of gene expression through number of mRNA copies transcribed for each gene) and in methylome.
Secondary objectives are to compare expression and methylation profiles according to:
- treatment response
- morphological (endoscopic and/or radiological) and clinical post-operating recurrence.
Read the detailed description
This aim of this study is to search for new biomarkers predictive of post-operating recurrence.
At present, there are no biomarkers predictive for post-operating recurrence and administration of a post-operating medical treatment to prevent recurrence is based on biological, endoscopic and imagery data.
Predictive biomarkers could allow the identification of patients with high risk of post-operating recurrence and administration of a systematic prophylactic post-operating treatment and at the same time avoiding the prescription of this treatment to patients with low risk of post-operating recurrence.
- Conditions
- Crohn Disease
- Being tested
- Ileocolic resection
- Keywords
- genomics, epigenomics, recurrence
- Medical subject headings
- Crohn Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileocolic resectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease | Not described Receives: Procedure: Ileocolic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression profile in intestinal operative specimens
Measured: up to 2 months (from resection)
Methylation profile in intestinal operative specimens
Measured: up to 2 months (from resection)
Secondary outcomes (3)
Digestive symptoms
such as abdominal pain, Koenig syndrome (abdominal pain relieved by flatus or feces expulsion), diarrhea
Measured: 6, 12, 24 months (after resection)
Radiological classification of recurrence with entero-MRI performed for post-operating follow-up of patients
Koilakou score, recurrence when score >=1
Measured: 6, 12, 24 months (after resection)
Evaluation of recurrence with endoscopy performed for post-operating follow-up of patients
Rutgeerts criteria (recurrence when score >=i1)
Measured: 6, 12, 24 months (after resection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeline GERMAIN, Principal investigator, Service de Chirurgie Digestive, Hépatobiliaire, Endocrinienne et Cancérologique CHRU Nancy Brabois Adultes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878395
- Sponsor's protocol ID
- PJC 2014/MICI-GERMAIN/MS
- Acronym
- PREDIPOSTOP
- Status last verified
- Aug 2016
- First submitted
- 22 Aug 2016
- Last updated
- 25 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 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases: Prediction of Post-operating Natural History of Crohn's Disease
- ClinicalTrials.gov ID
- NCT02878395
- Acronym / sponsor ID
- PREDIPOSTOP / PJC 2014/MICI-GERMAIN/MS
- Conditions
- Crohn Disease
- Keywords
- genomics, epigenomics, recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 25 Aug 2016 (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 is to search for enterocyte-specific or non-specific molecular signature of post-operating recurrence of Crohn's disease in transcriptome (measurement of gene expression through number of mRNA copies transcribed for each gene) and in methylome.
Secondary objectives are to compare expression and methylation profiles according to:
- treatment response
- morphological (endoscopic and/or radiological) and clinical post-operating recurrence.
Detailed description
This aim of this study is to search for new biomarkers predictive of post-operating recurrence.
At present, there are no biomarkers predictive for post-operating recurrence and administration of a post-operating medical treatment to prevent recurrence is based on biological, endoscopic and imagery data.
Predictive biomarkers could allow the identification of patients with high risk of post-operating recurrence and administration of a systematic prophylactic post-operating treatment and at the same time avoiding the prescription of this treatment to patients with low risk of post-operating recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease | – | Procedure: Ileocolic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Crohn's disease needing an ileocolic resection at CHRU Nancy.
Key inclusion criteria (3 listed)
- Patient with inflammatory bowel disease diagnosis based on clinical (abdominal pain, diarrhea and/or dysenteric syndrome, mostly muco-hemorrhagic, perianal injury, with sometimes general signs and /or systemic manifestations ), biological (inflammatory syndrome, deficiencies…), radiological (entero-MRI), endoscopic (presence of granulomatous lesions) and/or histological (epithelioid and giant cellular granuloma) data
- Patient undergoing ileocolic resection
- Patient affiliated to French social security
Key exclusion criteria (4 listed)
- Patient refusing sampling
- Patient with undetermined colitis
- Patient with non-confirmed diagnosis of inflammatory bowel disease
- Patient with inflammatory bowel disease not undergoing ileocolic resection
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 |
|---|---|---|
| Ileocolic resection | Procedure or surgery | Crohn's disease |
Primary outcome
Gene expression profile in intestinal operative specimens
Time frame: up to 2 months (from resection)
Methylation profile in intestinal operative specimens
Time frame: up to 2 months (from resection)
3 secondary outcomes
Digestive symptoms
Time frame: 6, 12, 24 months (after resection)
Radiological classification of recurrence with entero-MRI performed for post-operating follow-up of patients
Time frame: 6, 12, 24 months (after resection)
Evaluation of recurrence with endoscopy performed for post-operating follow-up of patients
Time frame: 6, 12, 24 months (after resection)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
Adeline GERMAIN contact
Adeline GERMAIN principal investigator
Service de Chirurgie Digestive, Hépatobiliaire, Endocrinienne et Cancérologique CHRU Nancy Brabois Adultes
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Central Hospital, Nancy, France.
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 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: status not confirmed, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adeline GERMAIN (a.germain@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression profile in intestinal operative specimens (time frame: up to 2 months (from resection)). The study lists 2 primary outcomes in all. 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 25 Aug 2016.