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Trial record 2 of 2 for:    Primary Sclerosing Cholangitis | Colorectal Cancer

Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease (DYSCOLIC)

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ClinicalTrials.gov Identifier: NCT02726243
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Build a collection of fecal microbiota in order to determine the characteristics of gut microbiota associated with colorectal cancer in Inflammatory bowel disease (IBD).

Condition or disease
Inflammatory Bowel Disease Colorectal Cancer

Detailed Description:

Inflammatory bowel disease (IBD) are chronic and relapsing disabling disease. Crohn's disease (CD) and Ulcerative colitis (UC) are the two main types of IBD.

Patients with IBD are at greater risk of intestinal infection including viral infections (including cytomegalovirus) and bacterial (especially Clostridium difficile). In the long term, patients with colonic involvement are at an increased risk of colorectal cancer (CRC). Moreover, it has been reported in several cohort studies that patients with primary sclerosing cholangitis (PSC) associated with IBD (PSC-IBD), have an even increased risk of CRC (about 10 to 20% at 10 years). Other studies also suggest that the microbiota has an impact on liver diseases. Conversely, cholestatic liver diseases (such as PSC) can influence the microbiota, notably through modification of the production of bile acids. Finally, the role of the gut microbiota in the development of the CRC in IBD has been well established in animal models. The pathophysiological mechanisms are not well understood but may involve an alteration of the balance between protective bacteria against harmful microbiota.

This study aims to investigate the link between gut microbiota, intestinal inflammation, colorectal cancer, bile acid and liver diseases and this, through the creation of a biological collection of fecal microbiota from fecal samples from 8 groups of subjects: (i) IBD without CCR (ii) IBD with CCR, (iii) IBD with dysplasia, (iv) non IBD without CCR, (v) non IBD with CCR, (vi) IBD-CSP without CCR, (vii ) IBD-CSP with CCR, (viii) IBD-CSP with dysplasia. In these patients, microbiota composition will be assessed by sequencing technology.


Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease - DYSCOLIC
Study Start Date : November 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort
IBD without CRC
IBD with CRC
IBD with dysplasia
non IBD without CRC
non IBD with CRC
IBD-PSC without CRC
IBD-PSC with CRC
IBD-PSC with dysplasia or healthy subjects
IBD-PSC with dysplasia or healthy subjects for whom a colonoscopy is scheduled



Primary Outcome Measures :
  1. Composition of fecal microbiota by 16S sequencing [ Time Frame: Baseline ]
    Microbiota composition will be assessed using MiSeq technology


Secondary Outcome Measures :
  1. Profile of fecal bile acids [ Time Frame: Baseline ]

    Characterize the profile of fecal bile acids of the patients included in the biological. collection. After extraction, the bile acid profile will be determined by LC-MS / MS (liquid chromatography coupled to tandem mass spectrometry).

    - Characterize some cultivable species of gut microbiota of patients included in the study by culture. Aerobic and anaerobic bacterial strains will be isolated from patients stools and stored for further characterization.



Biospecimen Retention:   Samples Without DNA
Stools


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with or without an inflammatory bowel disease, for whom a colonoscopy is scheduled.
Criteria

Inclusion Criteria:

  • Patient with the capacity to give informed consent.
  • Age ≥ 18 years.
  • A patient with IBD (Crohn's disease or ulcerative colitis) or healthy subject having a screening colonoscopy scheduled.
  • Diagnosis of pathologies in question established or confirmed in any of the services involved in the study and according to international diagnostic criteria (Consensus ECCO).
  • Patient follow-up in one of the services involved in the study

Exclusion Criteria:

  • trusteeship, guardianship or safeguard justice.
  • Subject does not speak French.
  • Subject unable to answer questions or to speak.
  • Previous history of colonic resection
  • Taking antibiotics within 8 weeks preceding the stool sample Temporary exclusion criterium)
  • Taking a bowel preparation for colonoscopy within 6 weeks before the stool sample (temporary exclusion criterium). Sampling is possible before bowel preparation or on the first stool after starting the bowel preparation.
  • Ostomy at the time of sampling
  • Current treatment by radiotherapy, chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726243


Contacts
Contact: Harry SOKOL, MD PhD (0)1 49 29 31 71 ext +33 harry.sokol@aphp.fr

Locations
France
Gastroenterology Department of Saint Antoine Hospital Recruiting
Paris, France, 75012
Contact: Harry SOKOL, MD, PhD    (0)1 49 29 31 71 ext +33    harry.sokol@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Harry SOKOL, MD PhD APHP

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02726243     History of Changes
Other Study ID Numbers: NI13006
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Inflammatory bowel disease
Crohn's Disease
Ulcerative Colitis
colorectal cancer
primary sclerosing cholangitis

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Diseases
Inflammatory Bowel Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Rectal Diseases
Gastroenteritis