Ovarian CystsNCT03189316
Anti-inflammatory Cells in Peritoneal Cavity
A study testing peritoneal fluid and blood sample in people with Ovarian Cysts and Chronic Renal Insufficiency, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ovarian Cysts, Chronic Renal Insufficiency
- What is being tested?
- peritoneal fluid and blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2017to 13 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- woman over 18 year old undergoing exploration of ovarian cysts by coelioscopy
- patient with chronic renal insufficiency undergoing peritoneal dialysis
- informed consent obtained
Who cannot join
- pregnancy or breast-feeding
- non affiliation to health care insurance
- treatment with corticosteroids over 15 mg/day
- treatment with rituximab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the Peritoneal Cavity be a Source of Regulatory B Cells to Treat Auto-immune Disease?
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.
Read the 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.
- Conditions
- Ovarian Cysts, Chronic Renal Insufficiency
- Being tested
- peritoneal fluid and blood sample
- Keywords
- Peritoneal fluid, B cells, Regulatory B cells, Human
- Medical subject headings
- Ovarian Cysts, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peritoneal fluid and blood sampleOther
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
| Study group | Role | What they receive |
|---|---|---|
| subjects with ovarian cyst | Other | Peritoneal fluid sample obtained from coelioscopy for exploration of ovarian cysts and blood sample Receives: 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 Receives: Other: peritoneal fluid and blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start6 Jun 2017
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
Why it stopped: Absence of BReg Lymphocytes in peritoneum
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CystsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189316
- Sponsor's protocol ID
- 9828
- Status last verified
- Jun 2018
- First submitted
- 30 May 2017
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Peritoneal Cavity be a Source of Regulatory B Cells to Treat Auto-immune Disease?
- ClinicalTrials.gov ID
- NCT03189316
- Acronym / sponsor ID
- 9828
- Conditions
- Ovarian Cysts, Chronic Renal Insufficiency
- Keywords
- Peritoneal fluid, B cells, Regulatory B cells, Human
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Absence of BReg Lymphocytes in peritoneum
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects with ovarian cyst | Other | Other: peritoneal fluid and blood samplePeritoneal fluid sample obtained from coelioscopy for exploration of ovarian cysts and blood sample |
| subjects with peritoneal dialysis | Other | Other: peritoneal fluid and blood samplePeritoneal fluid sample obtained from peritoneal dialysis fluid of patients with chronic renal insufficiency and blood sample |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- woman over 18 year old undergoing exploration of ovarian cysts by coelioscopy
- patient with chronic renal insufficiency undergoing peritoneal dialysis
- informed consent obtained
Key exclusion criteria (4 listed)
- pregnancy or breast-feeding
- non affiliation to health care insurance
- treatment with corticosteroids over 15 mg/day
- treatment with rituximab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peritoneal fluid and blood samplePeritoneal 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 | Other | subjects with ovarian cyst, subjects with peritoneal dialysis |
Primary outcome
relative percentage of regulatory B cells among B cells in peritoneal cavity compared to peripheral blood
Time frame: up to 48 hour
Comparison of Breg cell in peritoneal cavity to Breg cell in peripheral blood B
Results and safety
The study was stopped early (reason given: Absence of BReg Lymphocytes in peritoneum). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peritoneal fluid and blood sample in people with Ovarian Cysts and Chronic Renal Insufficiency, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Absence of BReg Lymphocytes in peritoneum). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative percentage of regulatory B cells among B cells in peritoneal cavity compared to peripheral blood (time frame: up to 48 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.