Evolution of Lymphocyte Populations Under Biotherapy in I... | NCT02693340

Studies
Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease

NCT02693340

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Jun 24, 2016Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Inflammatory Bowel Disease

Interventions

sampling

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Mar 2018Estimated

Completion Date

Mar 2020Estimated

First Submitted Date

Feb 23, 2016

First Submission Date that Met QC Criteria

Feb 23, 2016

First Posted Date

Feb 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2016

Last Update Posted Date

Jun 24, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a monocentric prospective study for the collection of biological samples (blood and biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive markers of response to biological treatments in inflammatory bowel disease (IBD).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
sampling	Biological	• Sampling period(s): Blood: W0, W6, W14, W30 and W52 and relapse. Biopsies and fecal: W0, W14 and M52 and relapse.

Measure	Description	Time Frame
Response to biological treatments		12 months

Measure	Description	Time Frame
Microbiota variation		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18 or more.
Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC) according to defined criteria (ECCO recommendations).
Active disease as defined by clinical biological and/or morphological assessment.
Initiation of an anti-Tumor Necrosis Factor (TNF) therapy (Infliximab, Adalimumab, Golimumab) or new biotherapy (Vedolizumab, Ustekinumab) provided in connection with the management of digestive disease.
Patient (e) have signed and dated consent of the study before undertaking procedures related to the study.

Exclusion Criteria:

Patients under guardianship / curators
Following Situations
- Persons unable to understand, read and / or sign an informed consent
- Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study
- Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year.
- No affiliation to a social security scheme, a universal medical coverage or any similar plan.
Pregnant or lactating women.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC)

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Matthieu Allez, MDPhD	Contact	+33 1 42 49 95 97		matthieu.allez@aphp.fr

Name	Affiliation	Role
Matthieu Allez, MD PhD	APHP	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Gastroenterology department	Recruiting	Paris	Paris	75010	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40920365	Derived	Veyssiere M, Hammoudi N, Le Bourhis L, Hassid D, Bonnet J, Tran Minh ML, Baudry C, Gornet JM, Chardiny V, Seksik P, Nancey S, Carbonnel F, Treton X, Wils P, Buisson A, Boureille A, Hebuterne X, Serrero M, Fumery M, Louis E, Blanc P, Peyrin-Biroulet L, Bezault M, Soumelis V, Allez M. Blood proteomic signatures associated with disease activity in inflammatory bowel diseases. J Crohns Colitis. 2025 Sep 28;19(9):jjaf162. doi: 10.1093/ecco-jcc/jjaf162.

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases