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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02973-38 | Registry Identifier | IDRCB |
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| Name | Class |
|---|---|
| National Research Agency, France | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD | Experimental | active or quiescent |
|
| control | Active Comparator | polyp screening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biopsy | Other | endoscopy biopsies (6) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validation of organoid-production method - quantity | Quantity of organoids created | Day 1 |
| Validation of organoid-production method - size | Size of organoids created | Day 1 |
| Validation of organoid-production method - cell growth | Cell-growth kinetics | Day 1 |
| Validation of organoid-production method - cell composition | Cell composition assessed by immunofluorescence | Day 1 |
| Validation of organoid-production method - cell composition | Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing | Day 1 |
| Validation of organoid-production method - cell apoptosis | Cell-apoptosis level assessed by immunofluorescence | Day 1 |
| Validation of organoid-production method - tight junctions | Number of tight junctions between cells assessed by immunofluorescence | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Screening-tool setup - quantity | Quantity of organoids after irradiation | Day 1 |
| Screening-tool setup - size | Size of organoids after irradiation |
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Inclusion criteria:
- Group 1: active IBD
Or
- Group 2: inactive IBD
Or
- Group 3: Control
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Ambroise Paré Hartmann | Neuilly-sur-Seine | Hauts-de-Seine | 92200 | France |
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| Day 1 |
| Screening-tool setup - cell growth | Cell-growth kinetics after irradiation | Day 1 |
| Screening-tool setup - cell composition | Cell composition after irradiation assessed by immunofluorescence | Day 1 |
| Screening-tool setup - cell apoptosis | Cell-apoptosis level after irradiation assessed by immunofluorescence | Day 1 |
| Screening-tool setup - tight junctions | Number of tight junctions between cells after irradiation assessed by immunofluorescence | Day 1 |
| Screening-tool setup - inflammatory cytokines | Level of inflammatory-cytokines produced after irradiation assessed by single-cell RNA sequencing | Day 1 |
| In-vitro treatment evaluation - quantity | Quantity of organoids after irradiation and in presence of treatment | Day 1 |
| In-vitro treatment evaluation - size | Size of organoids after irradiation and in presence of treatment | Day 1 |
| In-vitro treatment evaluation - cell growth | Cell-growth kinetics after irradiation and in presence of treatment | Day 1 |
| In-vitro treatment evaluation - cell composition | Cell composition after irradiation and in presence of treatment assessed by immunofluorescence | Day 1 |
| In-vitro treatment evaluation - cell composition | Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing | Day 1 |
| In-vitro treatment evaluation - cell apoptosis | Cell-apoptosis level after irradiation and in presence of treatment assessed by immunofluorescence | Day 1 |
| In-vitro treatment evaluation - tight junction | Number of tight junctions between cells after irradiation and in presence of treatment assessed by immunofluorescence | Day 1 |
| In-vitro treatment evaluation - inflammatory cytokines | Level of inflammatory-cytokines produced after irradiation and in presence of treatment assessed by single-cell RNA sequencing | Day 1 |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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