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Telomeres Evaluation in Endometriosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01809561
First Posted: March 12, 2013
Last Update Posted: April 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose

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.


Condition Intervention
Endometriosis Procedure: tissue biopsy during surgical treatment

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Weeks
Official Title: Telomeres Evaluation in Endometriosis

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
whole blood, endometrial tissue biopsy, lesion of endometriosis

Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women facing surgical treatment
Criteria

Inclusion Criteria:

  • women with suspected endometriosis facing surgical treatment

Exclusion Criteria:

  • no endometriosis on histology
  • malignant finding on histology
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809561


Contacts
Contact: Merav Sharvit, DR 972-9-7472561 merav.sharvit@gmail.com

Locations
Israel
OBGYN department, Meir Medical Center Not yet recruiting
Kfar-Saba, Israel
Contact: Merav Sharvit, DR       merav.sharvit@gmail.com   
Principal Investigator: Merav Sharvit, DR         
Sponsors and Collaborators
Meir Medical Center
Investigators
Study Chair: Ron Schonman, DR MeirMc, Israel
  More Information

Publications:

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01809561     History of Changes
Other Study ID Numbers: MMC13186-12CTIL
First Submitted: March 10, 2013
First Posted: March 12, 2013
Last Update Posted: April 9, 2013
Last Verified: February 2013

Keywords provided by Meir Medical Center:
endometriosis
telomere
telomerase

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female