The Immune Base of Endometriosis

This study has been withdrawn prior to enrollment.
(The study was withrawn do to logistic difficulties)
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00370123
First received: August 29, 2006
Last updated: June 26, 2011
Last verified: June 2011
  Purpose

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.


Condition
Endometriosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 50
Study Start Date: September 2006
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:

1. 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.

6. Endometrial tissue will be served ad antigenic source to generated T cell lines and the remnants will be stored at-70C for future studies.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women of childbrearing age suffering from endometriosis and undergoing laparoscopy

Criteria

Inclusion Criteria:

  • laparoscopically proven endometriosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370123

Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Chair: Mati Mandel, MD Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00370123     History of Changes
Other Study ID Numbers: SHEBA-06-4251-RM-CTIL
Study First Received: August 29, 2006
Last Updated: June 26, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
endometriosis
apoptosis
regulatory T cells

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014