Telomeres Evaluation in Endometriosis

April 7, 2013 updated by: Meir Medical Center

The purpose of the study is to assess the telomere array of different endometriosis tissue and endometrium from women with endometriosis compared to healthy women.

Our hypothesis is that telomere shortening and high telomerase activity will be found in tissues from women with endometriosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to assess the telomere array of different endometriosis tissue and endometrium from women with endometriosis compared to healthy women. Our hypothesis is that telomere shortening and high telomerase activity will be found in tissues from women with endometriosis, compared to women without endometriosis.

A prospective study that compares telomeres and telomerase levels in different lesions of endometriosis and endometrial tissue of women with endometriosis and healthy women without endometriosis. The study group will consist of women with suspected endometriosis facing surgical treatment and the control group will consist of healthy women facing gynecologic surgery for different indication.

We will sample endometrial tissue in both groups. In the study group we additionally will sample endometriosis lesion.

The samples collected will test for histological diagnosis of endometriosis and verification tests will be done to characterize the telomeres array and telomerase levels and other characteristics for genomic instability such as spontaneous aneuploidy.

expect telomere shortening and high telomerase activity in endometrial tissue and in endometriosis tissue sample, that won't characterize samples from women without endometriosis.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar-Saba, Israel
        • OBGYN department, Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women facing surgical treatment

Description

Inclusion Criteria:

  • women with suspected endometriosis facing surgical treatment

Exclusion Criteria:

  • no endometriosis on histology
  • malignant finding on histology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
endometriosis
The study group will consist of women with suspected endometriosis facing surgical treatment
Procedure: tissue biopsy during surgical treatment
The samples collected will test for histological diagnosis of endometriosis and verification tests will be done to characterize the telomeres array and telomerase levels and other characteristics for genomic instability such as spontaneous aneuploidy.
Other Names:
  • endometriosis tissue biopsy only study group
  • endometrial tissue biopsy
no endometriosis
The control group will consist of healthy women facing gynecologic surgery for different indication
Procedure: tissue biopsy during surgical treatment
The samples collected will test for histological diagnosis of endometriosis and verification tests will be done to characterize the telomeres array and telomerase levels and other characteristics for genomic instability such as spontaneous aneuploidy.
Other Names:
  • endometriosis tissue biopsy only study group
  • endometrial tissue biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
characterize the telomeres array and telomerase levels and other characteristics for genomic instability such as spontaneous aneuploidy in endometriosis tissue.
Time Frame: the tissue sample will colect at time of surgery
the tissue sample will colect at time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Study Chair: Ron Schonman, DR, MeirMc, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2015

Study Completion (ANTICIPATED)

February 1, 2015

Study Registration Dates

First Submitted

March 10, 2013

First Submitted That Met QC Criteria

March 10, 2013

First Posted (ESTIMATE)

March 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 9, 2013

Last Update Submitted That Met QC Criteria

April 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC13186-12CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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