Back to resultsPreclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids (INTRUST)
Primary Purpose
Radiation Enteritis, Inflammatory Bowel Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Radiation Enteritis focused on measuring colonoscopy
Eligibility Criteria
Inclusion criteria:
- Group 1: active IBD
- 18 years old or older
- Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to European Crohn's and Colitis Organisation (ECCO) 2019 consensus criteria
- Active IBD (Harvey-Bradshaw score of 4 or above for Crohn's disease or partial Mayo score of 3 or above for ulcerative colitis)
- Indication to perform a coloscopy
- Written consent for study participation obtained
Or
- Group 2: inactive IBD
- 18 years old or older
- Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to ECCO 2019 consensus criteria
- Inactive IBD (Harvey-Bradshaw score below 4 for Crohn's disease or partial Mayo score below 3 for ulcerative colitis)
- Indication to perform a coloscopy
- Written consent for study participation obtained
Or
- Group 3: Control
- 18 years old or older
- Indication to perform a coloscopy to detect polyp
- No known bowel disease
- Written consent for study participation obtained
Exclusion Criteria:
- Inability to understand, read, sign informed consent and/or express consent
- Person subject to legal protection (curator, guardianship or safeguard of justice),
- Deprivation of liberty by judicial or administrative decision,
- Non-affiliation to a social security scheme or non-beneficiary of such a scheme
- Pregnant, parturient, breastfeeding women
- Contraindication to performing biopsies
- Participation in other therapeutic research that may modify the behavior of intestinal cells (for example, drug research for the treatment of IBD)
- Anticoagulant treatment or bleeding disorder
- Person subject to a judicial safeguard measure
- People hospitalized without consent
Sites / Locations
- Groupe Hospitalier Ambroise Paré HartmannRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IBD
control
Arm Description
active or quiescent
polyp screening
Outcomes
Primary Outcome Measures
Validation of organoid-production method - quantity
Quantity of organoids created
Validation of organoid-production method - size
Size of organoids created
Validation of organoid-production method - cell growth
Cell-growth kinetics
Validation of organoid-production method - cell composition
Cell composition assessed by immunofluorescence
Validation of organoid-production method - cell composition
Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing
Validation of organoid-production method - cell apoptosis
Cell-apoptosis level assessed by immunofluorescence
Validation of organoid-production method - tight junctions
Number of tight junctions between cells assessed by immunofluorescence
Secondary Outcome Measures
Screening-tool setup - quantity
Quantity of organoids after irradiation
Screening-tool setup - size
Size of organoids after irradiation
Screening-tool setup - cell growth
Cell-growth kinetics after irradiation
Screening-tool setup - cell composition
Cell composition after irradiation assessed by immunofluorescence
Screening-tool setup - cell apoptosis
Cell-apoptosis level after irradiation assessed by immunofluorescence
Screening-tool setup - tight junctions
Number of tight junctions between cells after irradiation assessed by immunofluorescence
Screening-tool setup - inflammatory cytokines
Level of inflammatory-cytokines produced after irradiation assessed by single-cell RNA sequencing
In-vitro treatment evaluation - quantity
Quantity of organoids after irradiation and in presence of treatment
In-vitro treatment evaluation - size
Size of organoids after irradiation and in presence of treatment
In-vitro treatment evaluation - cell growth
Cell-growth kinetics after irradiation and in presence of treatment
In-vitro treatment evaluation - cell composition
Cell composition after irradiation and in presence of treatment assessed by immunofluorescence
In-vitro treatment evaluation - cell composition
Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing
In-vitro treatment evaluation - cell apoptosis
Cell-apoptosis level after irradiation and in presence of treatment assessed by immunofluorescence
In-vitro treatment evaluation - tight junction
Number of tight junctions between cells after irradiation and in presence of treatment assessed by immunofluorescence
In-vitro treatment evaluation - inflammatory cytokines
Level of inflammatory-cytokines produced after irradiation and in presence of treatment assessed by single-cell RNA sequencing
Full Information
NCT ID
NCT05425901
First Posted
June 10, 2022
Last Updated
June 21, 2023
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
National Research Agency, France
1. Study Identification
Unique Protocol Identification Number
NCT05425901
Brief Title
Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids
Acronym
INTRUST
Official Title
Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
September 18, 2025 (Anticipated)
Study Completion Date
September 18, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
National Research Agency, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is carried out in patients with IBD and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). It aims the generation and culturing of organoids from digestive biopsies recovered from healthy and/or pathological (inflammatory) ileal and/or colonic mucosa during an ileo-colonoscopy. These cultures will make it possible to validate the organoid production method used in the context of the research (primary objective). In a second phase (secondary objectives), the study will aim to setup a screening tool by irradiating the organoids (step one) and then evaluate in vitro the regenerative activity of treatments dedicated to improve inflammatory bowel diseases and acute radiation enteritis (step two).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Enteritis, Inflammatory Bowel Diseases
Keywords
colonoscopy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IBD
Arm Type
Experimental
Arm Description
active or quiescent
Arm Title
control
Arm Type
Active Comparator
Arm Description
polyp screening
Intervention Type
Other
Intervention Name(s)
biopsy
Intervention Description
endoscopy biopsies (6)
Primary Outcome Measure Information:
Title
Validation of organoid-production method - quantity
Description
Quantity of organoids created
Time Frame
Day 1
Title
Validation of organoid-production method - size
Description
Size of organoids created
Time Frame
Day 1
Title
Validation of organoid-production method - cell growth
Description
Cell-growth kinetics
Time Frame
Day 1
Title
Validation of organoid-production method - cell composition
Description
Cell composition assessed by immunofluorescence
Time Frame
Day 1
Title
Validation of organoid-production method - cell composition
Description
Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing
Time Frame
Day 1
Title
Validation of organoid-production method - cell apoptosis
Description
Cell-apoptosis level assessed by immunofluorescence
Time Frame
Day 1
Title
Validation of organoid-production method - tight junctions
Description
Number of tight junctions between cells assessed by immunofluorescence
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Screening-tool setup - quantity
Description
Quantity of organoids after irradiation
Time Frame
Day 1
Title
Screening-tool setup - size
Description
Size of organoids after irradiation
Time Frame
Day 1
Title
Screening-tool setup - cell growth
Description
Cell-growth kinetics after irradiation
Time Frame
Day 1
Title
Screening-tool setup - cell composition
Description
Cell composition after irradiation assessed by immunofluorescence
Time Frame
Day 1
Title
Screening-tool setup - cell apoptosis
Description
Cell-apoptosis level after irradiation assessed by immunofluorescence
Time Frame
Day 1
Title
Screening-tool setup - tight junctions
Description
Number of tight junctions between cells after irradiation assessed by immunofluorescence
Time Frame
Day 1
Title
Screening-tool setup - inflammatory cytokines
Description
Level of inflammatory-cytokines produced after irradiation assessed by single-cell RNA sequencing
Time Frame
Day 1
Title
In-vitro treatment evaluation - quantity
Description
Quantity of organoids after irradiation and in presence of treatment
Time Frame
Day 1
Title
In-vitro treatment evaluation - size
Description
Size of organoids after irradiation and in presence of treatment
Time Frame
Day 1
Title
In-vitro treatment evaluation - cell growth
Description
Cell-growth kinetics after irradiation and in presence of treatment
Time Frame
Day 1
Title
In-vitro treatment evaluation - cell composition
Description
Cell composition after irradiation and in presence of treatment assessed by immunofluorescence
Time Frame
Day 1
Title
In-vitro treatment evaluation - cell composition
Description
Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing
Time Frame
Day 1
Title
In-vitro treatment evaluation - cell apoptosis
Description
Cell-apoptosis level after irradiation and in presence of treatment assessed by immunofluorescence
Time Frame
Day 1
Title
In-vitro treatment evaluation - tight junction
Description
Number of tight junctions between cells after irradiation and in presence of treatment assessed by immunofluorescence
Time Frame
Day 1
Title
In-vitro treatment evaluation - inflammatory cytokines
Description
Level of inflammatory-cytokines produced after irradiation and in presence of treatment assessed by single-cell RNA sequencing
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
- Group 1: active IBD
18 years old or older
Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to European Crohn's and Colitis Organisation (ECCO) 2019 consensus criteria
Active IBD (Harvey-Bradshaw score of 4 or above for Crohn's disease or partial Mayo score of 3 or above for ulcerative colitis)
Indication to perform a coloscopy
Written consent for study participation obtained
Or
- Group 2: inactive IBD
18 years old or older
Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to ECCO 2019 consensus criteria
Inactive IBD (Harvey-Bradshaw score below 4 for Crohn's disease or partial Mayo score below 3 for ulcerative colitis)
Indication to perform a coloscopy
Written consent for study participation obtained
Or
- Group 3: Control
18 years old or older
Indication to perform a coloscopy to detect polyp
No known bowel disease
Written consent for study participation obtained
Exclusion Criteria:
Inability to understand, read, sign informed consent and/or express consent
Person subject to legal protection (curator, guardianship or safeguard of justice),
Deprivation of liberty by judicial or administrative decision,
Non-affiliation to a social security scheme or non-beneficiary of such a scheme
Pregnant, parturient, breastfeeding women
Contraindication to performing biopsies
Participation in other therapeutic research that may modify the behavior of intestinal cells (for example, drug research for the treatment of IBD)
Anticoagulant treatment or bleeding disorder
Person subject to a judicial safeguard measure
People hospitalized without consent
Facility Information:
Facility Name
Groupe Hospitalier Ambroise Paré Hartmann
City
Neuilly-sur-Seine
State/Province
Hauts-de-Seine
ZIP/Postal Code
92200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Treton, MD, PhD
Phone
+33146413178
Email
xavier.treton@institutdesmici.fr
12. IPD Sharing Statement
Learn more about this trial
Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids
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