EndometriosisNCT01809561
Telomeres Evaluation in Endometriosis
An observational study of Endometriosis, run by Meir Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 15 to 60 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- tissue biopsy during surgical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Feb 2015
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: women facing surgical treatment
Who may be able to join
- women with suspected endometriosis facing surgical treatment
Who cannot join
- no endometriosis on histology
- malignant finding on histology
Trial locations and contacts
1 site in 1 country.
Israel1 site
OBGYN department, Meir Medical Center
Kfar Saba, Israel
Merav Sharvit, DR, merav.sharvit@gmail.com
Merav Sharvit, DR
About this study
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- tissue biopsy during surgical treatment
- Keywords
- endometriosis, telomere, telomerase
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue biopsy during surgical treatmentProcedure or surgery
Also called endometriosis tissue biopsy only study group, endometrial tissue biopsy
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.
| Study group | Role | What they receive |
|---|---|---|
| endometriosis | The study group will consist of women with suspected endometriosis facing surgical treatment Receives: Procedure: tissue biopsy during surgical treatment | |
| no endometriosis | The control group will consist of healthy women facing gynecologic surgery for different indication Receives: Procedure: tissue biopsy during surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize the telomeres array and telomerase levels and other characteristics for genomic instability such as spontaneous aneuploidy in endometriosis tissue.
Measured: the tissue sample will colect at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Schonman, DR, Study chair, MeirMc, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809561
- Sponsor's protocol ID
- MMC13186-12CTIL
- Status last verified
- Feb 2013
- First submitted
- 10 Mar 2013
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sampson JA. Peritoneal endometriosis due to the menstrual dissemination of endometrial tissue into the peritoneal cavity. Am J Obstet Gynecol 1927 14,422-469.
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.
PubMed 11011865Wells 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.
PubMed 15381900Sharpe-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.
PubMed 11594534Nolan 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.
PubMed 1554145Jones 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.
PubMed 9886539Meresman 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.
PubMed 11020520Higashiura 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.
PubMed 22807950Amiel 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.
PubMed 16157205Amiel 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.
PubMed 16843101Saini 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.
PubMed 19627485Svenson 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.
PubMed 19419696Yokoyama 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.
PubMed 9542976Lehner 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.
PubMed 11748987Kim 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.
PubMed 17077107
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telomeres Evaluation in Endometriosis
- ClinicalTrials.gov ID
- NCT01809561
- Acronym / sponsor ID
- MMC13186-12CTIL
- Conditions
- Endometriosis
- Keywords
- endometriosis, telomere, telomerase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 12 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endometriosis | – | Procedure: tissue biopsy during surgical treatmentThe study group will consist of women with suspected endometriosis facing surgical treatment |
| no endometriosis | – | Procedure: tissue biopsy during surgical treatmentThe control group will consist of healthy women facing gynecologic surgery for different indication |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- women facing surgical treatment
Key inclusion criteria (1 listed)
- women with suspected endometriosis facing surgical treatment
Key exclusion criteria (2 listed)
- no endometriosis on histology
- malignant finding on histology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue biopsy during surgical treatmentAlso: endometriosis tissue biopsy only study group, endometrial tissue biopsyThe 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. | Procedure or surgery | endometriosis, no endometriosis |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- BackgroundSampson JA. Peritoneal endometriosis due to the menstrual dissemination of endometrial tissue into the peritoneal cavity. Am J Obstet Gynecol 1927 14,422-469.
- Background: PubMed 11011865Lapp 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.
- Background: PubMed 15381900Wells 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.
- Background: PubMed 11594534Sharpe-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.
- Background: PubMed 1554145Nolan 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.
- Background: PubMed 9886539Jones 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.
- Background: PubMed 11020520Meresman 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.
- Background: PubMed 22807950Higashiura 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.
- Background: PubMed 16157205Amiel 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.
- Background: PubMed 16843101Amiel 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.
- Background: PubMed 19627485Saini 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.
- Background: PubMed 19419696Svenson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Schonman, DR study chair
MeirMc, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merav Sharvit, DR (972-9-7472561, merav.sharvit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01809561, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.