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

Sponsor
Acibadem University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03687398
Collaborator
(none)
60
1
23
2.6

Study Details

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 Phase
  • 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
Anticipated 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 :
Oct 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm 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 [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

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Bahar Yuksel Istanbul Turkey 34104

Sponsors and Collaborators

  • Acibadem University

Investigators

  • Study Director: Bahar Yuksel, md

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Acibadem University
ClinicalTrials.gov Identifier:
NCT03687398
Other Study ID Numbers:
  • AcibademU endo
First Posted:
Sep 27, 2018
Last Update Posted:
Jul 9, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2019