Study Stopped
Absence of BReg Lymphocytes in peritoneum
Anti-inflammatory Cells in Peritoneal Cavity
Can the Peritoneal Cavity be a Source of Regulatory B Cells to Treat Auto-immune Disease?
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2017
CompletedStudy Start
First participant enrolled
June 6, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2017
CompletedJune 13, 2018
June 1, 2018
6 months
May 30, 2017
June 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
up to 48 hour
Study Arms (2)
subjects with ovarian cyst
OTHERPeritoneal fluid sample obtained from coelioscopy for exploration of ovarian cysts and blood sample
subjects with peritoneal dialysis
OTHERPeritoneal fluid sample obtained from peritoneal dialysis fluid of patients with chronic renal insufficiency and blood sample
Interventions
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
Eligibility Criteria
You may qualify if:
- woman over 18 year old undergoing exploration of ovarian cysts by coelioscopy
- patient with chronic renal insufficiency undergoing peritoneal dialysis
- informed consent obtained
You may not qualify if:
- pregnancy or breast-feeding
- non affiliation to health care insurance
- treatment with corticosteroids over 15 mg/day
- treatment with rituximab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU montpellier - department of rheumatology
Montpellier, 34295, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2017
First Posted
June 16, 2017
Study Start
June 6, 2017
Primary Completion
December 13, 2017
Study Completion
December 13, 2017
Last Updated
June 13, 2018
Record last verified: 2018-06