Back to resultsAnti-inflammatory Cells in Peritoneal Cavity
Primary Purpose
Ovarian Cysts, Chronic Renal Insufficiency
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
peritoneal fluid and blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Ovarian Cysts focused on measuring Peritoneal fluid, B cells, Regulatory B cells, Human
Eligibility Criteria
Inclusion criteria:
- woman over 18 year old undergoing exploration of ovarian cysts by coelioscopy
- patient with chronic renal insufficiency undergoing peritoneal dialysis
- informed consent obtained
Exclusion criteria:
- pregnancy or breast-feeding
- non affiliation to health care insurance
- treatment with corticosteroids over 15 mg/day
- treatment with rituximab
Sites / Locations
- CHU montpellier - department of rheumatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
subjects with ovarian cyst
subjects with peritoneal dialysis
Arm Description
Peritoneal fluid sample obtained from coelioscopy for exploration of ovarian cysts and blood sample
Peritoneal fluid sample obtained from peritoneal dialysis fluid of patients with chronic renal insufficiency and blood sample
Outcomes
Primary Outcome Measures
relative percentage of regulatory B cells among B cells in peritoneal cavity compared to peripheral blood
Comparison of Breg cell in peritoneal cavity to Breg cell in peripheral blood B
Secondary Outcome Measures
Full Information
NCT ID
NCT03189316
First Posted
May 30, 2017
Last Updated
June 12, 2018
Sponsor
University Hospital, Montpellier
Collaborators
Centre National de la Recherche Scientifique, France
1. Study Identification
Unique Protocol Identification Number
NCT03189316
Brief Title
Anti-inflammatory Cells in Peritoneal Cavity
Official Title
Can the Peritoneal Cavity be a Source of Regulatory B Cells to Treat Auto-immune Disease?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Absence of BReg Lymphocytes in peritoneum
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
December 13, 2017 (Actual)
Study Completion Date
December 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Centre National de la Recherche Scientifique, 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
Some subsets of lymphocytes are able to inhibit immune response and thus, could be used to control auto-immune diseases and transplant reject. In mice, the main source of those anti-inflammatory lymphocytes is the peritoneal cavity. No data are available in human. This study aims at exploring the presence of those anti-inflammatory lymphocytes in human peritoneal cavity and at determine how to expand those cells.
Detailed Description
B cells will be collected during procedures planned for patients' standard care. Peritoneal fluid and peripheral blood of patients will be collected during coelioscopy for exploration of ovarian cysts or dialysis for treatment of chronic renal insufficiency.
Regulatory B cells (Breg cells) will be measured in peritoneal fluid and in peripheral blood after in vitro stimulation and assessment of intracellular interleukin-10 by flow cytometry. Proportion of Breg cells among B cells will be compared between peritoneal fluid and peripheral blood in both groups.
Different protocols to induce differentiation of B cells into Breg cells will be tested and compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cysts, Chronic Renal Insufficiency
Keywords
Peritoneal fluid, B cells, Regulatory B cells, Human
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subjects with ovarian cyst
Arm Type
Other
Arm Description
Peritoneal fluid sample obtained from coelioscopy for exploration of ovarian cysts and blood sample
Arm Title
subjects with peritoneal dialysis
Arm Type
Other
Arm Description
Peritoneal fluid sample obtained from peritoneal dialysis fluid of patients with chronic renal insufficiency and blood sample
Intervention Type
Other
Intervention Name(s)
peritoneal fluid and blood sample
Intervention Description
Peritoneal fluid sample obtained from peritoneal dialysis fluid of patients with chronic renal insufficiency and blood sample or Peritoneal fluid obtained from coelioscopy for exploration of ovarian cysts and blood cell
Primary Outcome Measure Information:
Title
relative percentage of regulatory B cells among B cells in peritoneal cavity compared to peripheral blood
Description
Comparison of Breg cell in peritoneal cavity to Breg cell in peripheral blood B
Time Frame
up to 48 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
woman over 18 year old undergoing exploration of ovarian cysts by coelioscopy
patient with chronic renal insufficiency undergoing peritoneal dialysis
informed consent obtained
Exclusion criteria:
pregnancy or breast-feeding
non affiliation to health care insurance
treatment with corticosteroids over 15 mg/day
treatment with rituximab
Facility Information:
Facility Name
CHU montpellier - department of rheumatology
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Anti-inflammatory Cells in Peritoneal Cavity
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