Telomeres Evaluation in Endometriosis

NCT01809561 | Unknown DMC

• 1 other identifier: MMC13186-12CTIL
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Keywords

endometriosis; telomere; telomerase

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

endometriosis

The study group will consist of women with suspected endometriosis facing surgical treatment

Procedure: tissue biopsy during surgical treatment

no endometriosis

The control group will consist of healthy women facing gynecologic surgery for different indication

Procedure: tissue biopsy during surgical treatment

Interventions

tissue biopsy during surgical treatment PROCEDURE

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.

Also known as: endometriosis tissue biopsy only study group, endometrial tissue biopsy

endometriosis; no endometriosis

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women facing surgical treatment

You may qualify if:

• women with suspected endometriosis facing surgical treatment

You may not qualify if:

• no endometriosis on histology
• malignant finding on histology

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

OBGYN department, Meir Medical Center

Kfar Saba, Israel, Israel

Location

Related Publications (17)

• Sampson JA. Peritoneal endometriosis due to the menstrual dissemination of endometrial tissue into the peritoneal cavity. Am J Obstet Gynecol 1927 14,422-469.

  BACKGROUND

• 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. No abstract available.

  PMID: 11011865 BACKGROUND

• 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. doi: 10.1097/01.pgp.0000139636.94352.89.

  PMID: 15381900 BACKGROUND

• Sharpe-Timms KL. Endometrial anomalies in women with endometriosis. Ann N Y Acad Sci. 2001 Sep;943:131-47. doi: 10.1111/j.1749-6632.2001.tb03797.x.

  PMID: 11594534 BACKGROUND

• 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. doi: 10.1016/s0196-6553(05)80123-3. No abstract available.

  PMID: 1554145 BACKGROUND

• 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. doi: 10.1093/humrep/13.12.3496.

  PMID: 9886539 BACKGROUND

• 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. doi: 10.1016/s0015-0282(00)01522-3.

  PMID: 11020520 BACKGROUND

• 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. doi: 10.3892/ol.2012.690. Epub 2012 Apr 23.

  PMID: 22807950 BACKGROUND

• 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. doi: 10.1016/j.cancergencyto.2005.03.006.

  PMID: 16157205 BACKGROUND

• 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. doi: 10.1016/j.cancergencyto.2006.02.002.

  PMID: 16843101 BACKGROUND

• 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.

  PMID: 19627485 BACKGROUND

• 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.

  PMID: 19419696 BACKGROUND

• 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. doi: 10.1093/molehr/4.2.173.

  PMID: 9542976 BACKGROUND

• 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. doi: 10.1006/gyno.2001.6474.

  PMID: 11748987 BACKGROUND

• 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. doi: 10.1093/humrep/del425. Epub 2006 Oct 31.

  PMID: 17077107 BACKGROUND

• 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.

  PMID: 18456668 BACKGROUND

• 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.

  PMID: 6234483 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, endometrial tissue biopsy, lesion of endometriosis

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ron Schonman, DR

  MeirMc, Israel

  STUDY CHAIR

Central Study Contacts

Merav Sharvit, DR

CONTACT

972-9-7472561; merav.sharvit@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2013
• First Posted: March 12, 2013
• Study Start: May 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 9, 2013

Record last verified: 2013-02

Locations

IL (1)