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

Endometriosis Clinical Trial

Official title:

Comparison of Genomic Maps of Endometrial Tissues of Patients With Endometriosis and Healthy Controls Via Nanochannel Technique and Proteomic-genomic Analyzes.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03687398
• Other study ID #: AcibademU endo
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2019
• Source: Acibadem University
• Contact: Bahar Yuksel, md
• Phone: 05424732003
• Email: baharyl86[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

surgically diagnosed with endometriosis disease

• no diagnosis 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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis

Intervention

Diagnostic Test:
• genetic testing with nanoclonal technique
endometrial sampling

Locations

Country	Name	City	State
Turkey	Bahar Yuksel	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 tech — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic testing	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	2 years