Telomeres Evaluation in Endometriosis

Endometriosis Clinical Trial

Official title:

Telomeres Evaluation in Endometriosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01809561
• Other study ID #: MMC13186-12CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: March 10, 2013
• Last updated: April 7, 2013
• Start date: May 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2013
• Source: Meir Medical Center
• Contact: Merav Sharvit, DR
• Phone: 972-9-7472561
• Email: merav.sharvit[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• women with suspected endometriosis facing surgical treatment

Exclusion Criteria:

• no endometriosis on histology

• malignant finding on histology

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
Israel	OBGYN department, Meir Medical Center	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (17)

Amiel A, Gronich N, Yukla M, Suliman S, Josef G, Gaber E, Drori G, Fejgin MD, Lishner M. Random aneuploidy in neoplastic and pre-neoplastic diseases, multiple myeloma, and monoclonal gammopathy. Cancer Genet Cytogenet. 2005 Oct 1;162(1):78-81. — View Citation

Amiel A, Yukla M, Gaber E, Leopold L, Josef G, Fejgin M, Lishner M. Random aneuploidy in CML patients at diagnosis and under imatinib treatment. Cancer Genet Cytogenet. 2006 Jul 15;168(2):120-3. — View Citation

Halme J, Hammond MG, Hulka JF, Raj SG, Talbert LM. Retrograde menstruation in healthy women and in patients with endometriosis. Obstet Gynecol. 1984 Aug;64(2):151-4. — View Citation

Hapangama DK, Turner MA, Drury JA, Quenby S, Saretzki G, Martin-Ruiz C, Von Zglinicki T. Endometriosis is associated with aberrant endometrial expression of telomerase and increased telomere length. Hum Reprod. 2008 Jul;23(7):1511-9. doi: 10.1093/humrep/den172. Epub 2008 May 2. — View Citation

Higashiura Y, Kajihara H, Shigetomi H, Kobayashi H. Identification of multiple pathways involved in the malignant transformation of endometriosis (Review). Oncol Lett. 2012 Jul;4(1):3-9. Epub 2012 Apr 23. — View Citation

Jones RK, Searle RF, Bulmer JN. Apoptosis and bcl-2 expression in normal human endometrium, endometriosis and adenomyosis. Hum Reprod. 1998 Dec;13(12):3496-502. — View Citation

Kim CM, Oh YJ, Cho SH, Chung DJ, Hwang JY, Park KH, Cho DJ, Choi YM, Lee BS. Increased telomerase activity and human telomerase reverse transcriptase mRNA expression in the endometrium of patients with endometriosis. Hum Reprod. 2007 Mar;22(3):843-9. Epub 2006 Oct 31. — View Citation

Lapp T. ACOG issues recommendations for the management of endometriosis. American College of Obstetricians and Gynecologists. Am Fam Physician. 2000 Sep 15;62(6):1431, 1434. — View Citation

Lehner R, Enomoto T, McGregor JA, Shroyer AL, Haugen BR, Pugazhenthi U, Shroyer KR. Quantitative analysis of telomerase hTERT mRNA and telomerase activity in endometrioid adenocarcinoma and in normal endometrium. Gynecol Oncol. 2002 Jan;84(1):120-5. — View Citation

Meresman GF, Vighi S, Buquet RA, Contreras-Ortiz O, Tesone M, Rumi LS. Apoptosis and expression of Bcl-2 and Bax in eutopic endometrium from women with endometriosis. Fertil Steril. 2000 Oct;74(4):760-6. — View Citation

Nolan CM. Human immunodeficiency syndrome-associated tuberculosis: a review with an emphasis on infection control issues. Am J Infect Control. 1992 Feb;20(1):30-4. Review. — View Citation

Saini N, Srinivasan R, Chawla Y, Sharma S, Chakraborti A, Rajwanshi A. Telomerase activity, telomere length and human telomerase reverse transcriptase expression in hepatocellular carcinoma is independent of hepatitis virus status. Liver Int. 2009 Sep;29(8):1162-70. doi: 10.1111/j.1478-3231.2009.02082.x. Epub 2009 Jul 17. — View Citation

Sampson JA. Metastatic or Embolic Endometriosis, due to the Menstrual Dissemination of Endometrial Tissue into the Venous Circulation. Am J Pathol. 1927 Mar;3(2):93-110.43. — View Citation

Sharpe-Timms KL. Endometrial anomalies in women with endometriosis. Ann N Y Acad Sci. 2001 Sep;943:131-47. Review. — View Citation

Svenson U, Roos G. Telomere length as a biological marker in malignancy. Biochim Biophys Acta. 2009 Apr;1792(4):317-23. doi: 10.1016/j.bbadis.2009.01.017. Epub 2009 Feb 7. Review. — View Citation

Wells M. Recent advances in endometriosis with emphasis on pathogenesis, molecular pathology, and neoplastic transformation. Int J Gynecol Pathol. 2004 Oct;23(4):316-20. Review. — View Citation

Yokoyama Y, Takahashi Y, Morishita S, Hashimoto M, Niwa K, Tamaya T. Telomerase activity in the human endometrium throughout the menstrual cycle. Mol Hum Reprod. 1998 Feb;4(2):173-7. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	characterize the telomeres array and telomerase levels and other characteristics for genomic instability such as spontaneous aneuploidy in endometriosis tissue.		the tissue sample will colect at time of surgery	No