EndometriosisNCT00370123
The Immune Base of Endometriosis
An observational study of Endometriosis, run by Sheba Medical Center.
Trial summary
Endometriosis is a chronic disabling inflammatory disease which effects 15-20% of women in their reproductive life. In patients suffering from endometriosis retrograded menstrual cells induce an inflammatory response.Endometriosis has also been considered to be an autoimmune disease, owing to the presence of auto… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to not given
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women of childbrearing age suffering from endometriosis and undergoing laparoscopy
Who may be able to join
- laparoscopically proven endometriosis
Who cannot join
None listed.
About this study
Official title: In This Study we Aim to Explore the Immune Nature of Endometriosis as Manifested in the Peripheral Blood, Endometriosis Lesions, Normal Peritoneum and Normal Endometrium of Patients Suffering From Documented Endometriosis.
Endometriosis is a chronic disabling inflammatory disease which effects 15-20% of women in their reproductive life.
In patients suffering from endometriosis retrograded menstrual cells induce an inflammatory response.Endometriosis has also been considered to be an autoimmune disease, owing to the presence of auto antibodies, the association with other autoimmune diseases and recurrent immune-mediated abortion.
Read more
We aim to study this aberrant regulation of endometrial cell apoptosis by investigating the peripheral blood immune system of patients suffering from endometriosis.
Hypothesis:
We hypothesized that immune peripheral mononuclear cells of patients suffering from pelvic endometriosis react differently to eutopic endometrial cells than matched control women group. This difference could be study on a molecular, antigenic and/or apoptotic cycle gene expression. We also hypothesized that a deficiency of regulatory T cells is associated with the progression of endometriosis.
Read the detailed description
Endometriosis affects 15-20% of women in their reproductive life. Endometriosis is a chronic disabling inflammatory disease, characterized by implantation and growth of endometrial tissue (glandular epithelium and stroma) outside the uterine cavity.
Retrograde menstruation was found in 80%-90% of women. In most women these endometrial cells undergo apoptosis. In patients suffering from endometriosis this cells induce an inflammatory response. Pelvic endometriosis is associated with intrinsic anomalies of the refluxed endometrium, increased secretion of pro-inflammatory cytokines, neoangiogenesis, and impaired function of cell-mediated natural immunity.
Endometriosis has also been considered to be an autoimmune disease, owing to the presence of auto antibodies, the association with other autoimmune diseases and recurrent immune-mediated abortion.
Evidence suggests that Foxp3-expressing CD4+CD25+ regulatory T cells play a crucial role in the suppression of inflammatory disease. However, their role in the suppression of endometriosis has not yet been addressed.
We aim to study this aberrant regulation of endometrial cell apoptosis by investigating the peripheral blood immune system of patients suffering from endometriosis.
Hypothesis:
We hypothesized that immune peripheral mononuclear cells of patients suffering from pelvic endometriosis react differently to eutopic endometrial cells than matched control women group. This difference could be study on a molecular, antigenic and/or apoptotic cycle gene expression. We also hypothesized that a deficiency of regulatory T cells is associated with the progression of endometriosis.
Study design:
This is an open labeled prospective in vitro study for two years.
Patients:
50 Patients suffering from endometriosis undergoing laparoscopy will be compared to 50 patients undergoing laparoscopy for other reasons.
Methods:
- Blood withdrawal and pipelle endometrial cells harvesting 2. Isolation of peripheral blood mononuclear cells (PBMC) 3. Generation of T cell lines (from patients) 4. Measurement of cytokines 5. Determination of T- cell subsets by flow cytometry 5. PMNC and T cell lines will be frozen in liquid nitrogen and stored at-70C for future studies.
- Endometrial tissue will be served ad antigenic source to generated T cell lines and the remnants will be stored at-70C for future studies.
- Conditions
- Endometriosis
- Keywords
- endometriosis, apoptosis, regulatory T cells
- Medical subject headings
- Endometriosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2006 (estimated)
- Study startSep 2006
Why it stopped: The study was withrawn do to logistic difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Mati Mandel, MD, Study chair, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370123
- Sponsor's protocol ID
- SHEBA-06-4251-RM-CTIL
- Status last verified
- Jun 2011
- First submitted
- 29 Aug 2006
- Last updated
- 28 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In This Study we Aim to Explore the Immune Nature of Endometriosis as Manifested in the Peripheral Blood, Endometriosis Lesions, Normal Peritoneum and Normal Endometrium of Patients Suffering From Documented Endometriosis.
- ClinicalTrials.gov ID
- NCT00370123
- Acronym / sponsor ID
- SHEBA-06-4251-RM-CTIL
- Conditions
- Endometriosis
- Keywords
- endometriosis, apoptosis, regulatory T cells
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was withrawn do to logistic difficulties
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2006
- First posted
- 30 Aug 2006 (estimated)
- 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.
Endometriosis is a chronic disabling inflammatory disease which effects 15-20% of women in their reproductive life.
In patients suffering from endometriosis retrograded menstrual cells induce an inflammatory response.Endometriosis has also been considered to be an autoimmune disease, owing to the presence of auto antibodies, the association with other autoimmune diseases and recurrent immune-mediated abortion.
We aim to study this aberrant regulation of endometrial cell apoptosis by investigating the peripheral blood immune system of patients suffering from endometriosis.
Hypothesis:
We hypothesized that immune peripheral mononuclear cells of patients suffering from pelvic endometriosis react differently to eutopic endometrial cells than matched control women group. This difference could be study on a molecular, antigenic and/or apoptotic cycle gene expression. We also hypothesized that a deficiency of regulatory T cells is associated with the progression of endometriosis.
Detailed description
Endometriosis affects 15-20% of women in their reproductive life. Endometriosis is a chronic disabling inflammatory disease, characterized by implantation and growth of endometrial tissue (glandular epithelium and stroma) outside the uterine cavity.
Retrograde menstruation was found in 80%-90% of women. In most women these endometrial cells undergo apoptosis. In patients suffering from endometriosis this cells induce an inflammatory response. Pelvic endometriosis is associated with intrinsic anomalies of the refluxed endometrium, increased secretion of pro-inflammatory cytokines, neoangiogenesis, and impaired function of cell-mediated natural immunity.
Endometriosis has also been considered to be an autoimmune disease, owing to the presence of auto antibodies, the association with other autoimmune diseases and recurrent immune-mediated abortion.
Evidence suggests that Foxp3-expressing CD4+CD25+ regulatory T cells play a crucial role in the suppression of inflammatory disease. However, their role in the suppression of endometriosis has not yet been addressed.
We aim to study this aberrant regulation of endometrial cell apoptosis by investigating the peripheral blood immune system of patients suffering from endometriosis.
Hypothesis:
We hypothesized that immune peripheral mononuclear cells of patients suffering from pelvic endometriosis react differently to eutopic endometrial cells than matched control women group. This difference could be study on a molecular, antigenic and/or apoptotic cycle gene expression. We also hypothesized that a deficiency of regulatory T cells is associated with the progression of endometriosis.
Study design:
This is an open labeled prospective in vitro study for two years.
Patients:
50 Patients suffering from endometriosis undergoing laparoscopy will be compared to 50 patients undergoing laparoscopy for other reasons.
Methods:
- Blood withdrawal and pipelle endometrial cells harvesting 2. Isolation of peripheral blood mononuclear cells (PBMC) 3. Generation of T cell lines (from patients) 4. Measurement of cytokines 5. Determination of T- cell subsets by flow cytometry 5. PMNC and T cell lines will be frozen in liquid nitrogen and stored at-70C for future studies.
- Endometrial tissue will be served ad antigenic source to generated T cell lines and the remnants will be stored at-70C for future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women of childbrearing age suffering from endometriosis and undergoing laparoscopy
Key inclusion criteria (1 listed)
- laparoscopically proven endometriosis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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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.
Mati Mandel, MD study chair
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Sheba Medical Center.
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 1 inclusion and 0 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: withdrawn, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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.
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 28 Jun 2011.