Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-01-09 @ 5:34 PM
Study NCT ID:
NCT01809561
Status:
UNKNOWN
Last Update Posted:
2013-04-09
First Post:
2013-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telomeres Evaluation in Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, endometrial tissue biopsy, lesion of endometriosis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-07', 'studyFirstSubmitDate': '2013-03-10', 'studyFirstSubmitQcDate': '2013-03-10', 'lastUpdatePostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'characterize the telomeres array and telomerase levels and other characteristics for genomic instability such as spontaneous aneuploidy in endometriosis tissue.', 'timeFrame': 'the tissue sample will colect at time of surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['endometriosis', 'telomere', 'telomerase'], 'conditions': ['Endometriosis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Sampson JA. Peritoneal endometriosis due to the menstrual dissemination of endometrial tissue into the peritoneal cavity. Am J Obstet Gynecol 1927 14,422-469.'}, {'pmid': '11011865', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '15381900', 'type': 'BACKGROUND', '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. doi: 10.1097/01.pgp.0000139636.94352.89.'}, {'pmid': '11594534', 'type': 'BACKGROUND', 'citation': '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': '1554145', 'type': 'BACKGROUND', '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. doi: 10.1016/s0196-6553(05)80123-3. No abstract available.'}, {'pmid': '9886539', 'type': 'BACKGROUND', '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. doi: 10.1093/humrep/13.12.3496.'}, {'pmid': '11020520', 'type': 'BACKGROUND', '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. doi: 10.1016/s0015-0282(00)01522-3.'}, {'pmid': '22807950', 'type': 'BACKGROUND', '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. doi: 10.3892/ol.2012.690. Epub 2012 Apr 23.'}, {'pmid': '16157205', 'type': 'BACKGROUND', 'citation': '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': '16843101', 'type': 'BACKGROUND', '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. doi: 10.1016/j.cancergencyto.2006.02.002.'}, {'pmid': '19627485', 'type': 'BACKGROUND', '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.'}, {'pmid': '19419696', 'type': 'BACKGROUND', '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.'}, {'pmid': '9542976', 'type': 'BACKGROUND', '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. doi: 10.1093/molehr/4.2.173.'}, {'pmid': '11748987', 'type': 'BACKGROUND', '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. doi: 10.1006/gyno.2001.6474.'}, {'pmid': '17077107', 'type': 'BACKGROUND', '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. doi: 10.1093/humrep/del425. Epub 2006 Oct 31.'}, {'pmid': '18456668', 'type': 'BACKGROUND', '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.'}, {'pmid': '6234483', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nOur hypothesis is that telomere shortening and high telomerase activity will be found in tissues from women with endometriosis.', 'detailedDescription': "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.\n\nA 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.\n\nWe will sample endometrial tissue in both groups. In the study group we additionally will sample endometriosis lesion.\n\nThe 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.\n\nexpect telomere shortening and high telomerase activity in endometrial tissue and in endometriosis tissue sample, that won't characterize samples from women without endometriosis."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women facing surgical treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with suspected endometriosis facing surgical treatment\n\nExclusion Criteria:\n\n* no endometriosis on histology\n* malignant finding on histology'}, 'identificationModule': {'nctId': 'NCT01809561', 'briefTitle': 'Telomeres Evaluation in Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Telomeres Evaluation in Endometriosis', 'orgStudyIdInfo': {'id': 'MMC13186-12CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'endometriosis', 'description': 'The study group will consist of women with suspected endometriosis facing surgical treatment', 'interventionNames': ['Procedure: tissue biopsy during surgical treatment']}, {'label': 'no endometriosis', 'description': 'The control group will consist of healthy women facing gynecologic surgery for different indication', 'interventionNames': ['Procedure: tissue biopsy during surgical treatment']}], 'interventions': [{'name': 'tissue biopsy during surgical treatment', 'type': 'PROCEDURE', 'otherNames': ['endometriosis tissue biopsy only study group', 'endometrial tissue biopsy'], 'description': '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.', 'armGroupLabels': ['endometriosis', 'no endometriosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'state': 'Israel', 'country': 'Israel', 'contacts': [{'name': 'Merav Sharvit, DR', 'role': 'CONTACT', 'email': 'merav.sharvit@gmail.com'}, {'name': 'Merav Sharvit, DR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OBGYN department, Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Merav Sharvit, DR', 'role': 'CONTACT', 'email': 'merav.sharvit@gmail.com', 'phone': '972-9-7472561'}], 'overallOfficials': [{'name': 'Ron Schonman, DR', 'role': 'STUDY_CHAIR', 'affiliation': 'MeirMc, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}