NCT03189316

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

June 6, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

May 30, 2017

Last Update Submit

June 12, 2018

Conditions

Keywords

Peritoneal fluidB cellsRegulatory B cellsHuman

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

OTHER

Peritoneal fluid sample obtained from coelioscopy for exploration of ovarian cysts and blood sample

Other: peritoneal fluid and blood sample

subjects with peritoneal dialysis

OTHER

Peritoneal fluid sample obtained from peritoneal dialysis fluid of patients with chronic renal insufficiency and blood sample

Other: peritoneal fluid 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

subjects with ovarian cystsubjects with peritoneal dialysis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Ovarian CystsRenal Insufficiency, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

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

Locations