NCT03687398

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

1.8 years

First QC Date

September 16, 2018

Last Update Submit

July 6, 2019

Conditions

EndometriosisEndometrioma

Keywords

genetic analysisendometriosisnanoclonalcopy number

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

patient

has laparoscopically proven endometriosis

Diagnostic Test: genetic testing with nanoclonal technique

Interventions

genetic testing with nanoclonal techniqueDIAGNOSTIC_TEST

endometrial sampling

controlpatient

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly seen in females
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahar Yuksel

Istanbul, 34104, Turkey (Türkiye)

RECRUITING

Related 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 technology. Gigascience. 2014 Dec 30;3(1):34. doi: 10.1186/2047-217X-3-34. eCollection 2014.

    PMID: 25671094RESULT

  • 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.

    PMID: 24639062RESULT

MeSH Terms

Conditions

Endometriosis

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Bahar Yuksel

    md

    STUDY DIRECTOR

Central Study Contacts

Bahar Yuksel, md

CONTACT

05424732003baharyl86@gmail.com

ercan bastu, md

CONTACT

ercanbastu@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2018

First Posted

September 27, 2018

Study Start

October 1, 2018

Primary Completion

August 1, 2020

Study Completion

September 1, 2020

Last Updated

July 9, 2019

Record last verified: 2019-07

Locations

TU(1)