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

NCT ID: NCT03687398

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endometriosis Endometrioma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control

does not have endometriosis or related diseases and not under any drug therapy does not have any benign or malign disease

genetic testing with nanoclonal technique

Intervention Type DIAGNOSTIC_TEST

endometrial sampling

patient

has laparoscopically proven endometriosis

genetic testing with nanoclonal technique

Intervention Type DIAGNOSTIC_TEST

endometrial sampling

Interventions

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genetic testing with nanoclonal technique

endometrial sampling

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bahar Yuksel

Role: STUDY_DIRECTOR

md

Locations

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Bahar Yuksel

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Bahar Yuksel, md

Role: CONTACT

05424732003

ercan bastu, md

Role: CONTACT

Facility Contacts

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Bahar Yuksel

Role: primary

5424732003

References

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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.

Reference Type RESULT
PMID: 25671094 (View on PubMed)

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.

Reference Type RESULT
PMID: 24639062 (View on PubMed)

Other Identifiers

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AcibademU endo

Identifier Type: -

Identifier Source: org_study_id

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