Genomic Maps of Endometrial Tissues of Patients With Endometriosis and Healthy Controls

• ClinicalTrials.gov Identifier: NCT03687398
• Recruitment Status: Unknown
• First Posted: September 27, 2018
• Last Update Posted: July 9, 2019
• Sponsor: Acibadem University
• Information provided by (Responsible Party): Acibadem University

Study Description

Brief Summary:

Endometriosis is a chronic inflammatory disease that affects 10-17% of women in childbearing age, 35-60% of women with chronic pelvic pain and can cause infertility, costing as much as 2.8 billion dollars per year. For this reason, every step taken in diagnosis and treatment is of great importance both materially and spiritually. Patients can be diagnosed about 8-9 years after the onset of their complaints due to inadequacy of diagnostic methods In the study, it is decided to look at the basis of the disease, endometrial cells. And aimed to find the difference between the two women who are thought to be no different from each other among our current knowledge but one has endometriosis while other have not.

Condition or disease	Intervention/treatment
Endometriosis; Endometrioma	Diagnostic Test: genetic testing with nanoclonal technique

Detailed Description:

Endometriosis is the appearance of a tissue similar to the endometrium in the ovaries, large intestine, and many other organ walls, except the uterus. The reason is unknown yet. Severe periodic pain, infertility, and pain during intercourse, affects approximately 2 million women in Turkey on average, 10% of women around the world. Endometriosis is a chronic inflammatory disease that affects 10-17% of women in childbearing age, 35-60% of women with chronic pelvic pain and can cause infertility, costing as much as 2.8 billion dollars per year. For this reason, every step taken in diagnosis and treatment is of great importance both materially and spiritually. Patients can be diagnosed about 8-9 years after the onset of their complaints due to the inadequacy of diagnostic methods In the study, it is decided to look at the basis of the disease, endometrial cells. And aimed to find the difference between the two women who are thought to be no different from each other among our current knowledge but one has endometriosis while others have not. For this reason, mapping of all genomes with the nanoclonal technique, the most advanced genetic screening method currently available from endometrial samples of patients and healthy women, is to identify the possible copy numbers, translocation, insertion and inversion anomalies, and to name them functionally by proteomic analysis. We believe that the results obtained from our study will guide the diagnostic tests and possible gene therapy in the future.

Study Design

• Study Type: Observational
• Estimated Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Comparison of Genomic Maps of Endometrial Tissues of Patients With Endometriosis and Healthy Controls Via Nanochannel Technique and Proteomic-genomic Analyzes.
• Actual Study Start Date: October 1, 2018
• Estimated Primary Completion Date: August 1, 2020
• Estimated Study Completion Date: September 1, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
control; does not have endometriosis or related diseases and not under any drug therapy does not have any benign or malign disease	Diagnostic Test: genetic testing with nanoclonal technique; endometrial sampling
patient; has laparoscopically proven endometriosis	Diagnostic Test: genetic testing with nanoclonal technique; endometrial sampling

Outcome Measures

Primary Outcome Measures :

1. diagnostic testing [ Time Frame: 2 years ]
   finding a genetic difference which specifically preserved in endometriosis patients but not in healthy controls. To analyse the different region on chromosomes and name the pathophysiology underlying it

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: only seen in females
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

patients who are :

• surgically diagnosed with endometriosis disease
• have no diagnosıs for malignancy
• gave informed consent for application to the study enrolle as patient group

females

• between 18-45 years old
• without any health conditions
• applied to the clinic for routine checkups are going to be taken as the control group

Criteria

Inclusion Criteria:

surgically diagnosed with endometriosis disease

• no diagnosıs for malignancy
• gave informed consent for application to the study enrolle as patient group females
• between 18-45 years old
• without any health conditions
• applied to the clinic for routine checkups for control group

Exclusion Criteria:

• being diagnosed with any kind of malignancy having trouble with endometrial cavity sampling

Contacts and Locations

Contacts

Contact: Bahar Yuksel, md; 05424732003; baharyl86@gmail.com

Contact: ercan bastu, md; ercanbastu@gmail.com

Locations

Turkey

Bahar Yuksel; Recruiting

Istanbul, Turkey, 34104

Contact: Bahar Yuksel 5424732003 baharyl86@gmail.com

Sponsors and Collaborators

Acibadem University

Investigators

• Study Director: Bahar Yuksel; md

More Information

Publications of Results:

Cao H, Hastie AR, Cao D, Lam ET, Sun Y, Huang H, Liu X, Lin L, Andrews W, Chan S, Huang S, Tong X, Requa M, Anantharaman T, Krogh A, Yang H, Cao H, Xu X. Rapid detection of structural variation in a human genome using nanochannel-based genome mapping technology. Gigascience. 2014 Dec 30;3(1):34. doi: 10.1186/2047-217X-3-34. eCollection 2014.

Kobayashi H, Imanaka S, Nakamura H, Tsuji A. Understanding the role of epigenomic, genomic and genetic alterations in the development of endometriosis (review). Mol Med Rep. 2014 May;9(5):1483-505. doi: 10.3892/mmr.2014.2057. Epub 2014 Mar 14. Review.

• Responsible Party: Acibadem University
• ClinicalTrials.gov Identifier: NCT03687398
• Other Study ID Numbers: AcibademU endo
• First Posted: September 27, 2018
• Last Update Posted: July 9, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Acibadem University:

genetic analysis; endometriosis; nanoclonal; copy number

Additional relevant MeSH terms:

Endometriosis