ClinicalTrials.gg
Status unknownNCT03687398Updated Jul 9, 2019

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

An observational study in Endometriosis and Endometrioma, sponsored by Acibadem University. Status unknown at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-09.

Sponsored by Acibadem University · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Endometriosis
  • Endometrioma

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Keywords

  • genetic analysis
  • endometriosis
  • nanoclonal
  • copy number
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In context

Endometriosis

925 studies on the registry are indexed under Endometriosis; 264 are open to participants now.

This study's planned enrollment of 60 is below the median of 125 across 354 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Acibadem University is the lead sponsor of 218 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testgenetic testing with nanoclonal technique

    endometrial sampling

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What researchers measure

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

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Bahar Yuksel
    Istanbul, 34104, Turkey (Türkiye)
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25671094 ↗
  • 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. PubMed 24639062 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2018 (actual). Primary completion is estimated for Aug 2020, 22 months after the start.

Of 153 non-industry observational studies under Endometriosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 22 months is below that.

Counting every sponsor, half of 182 studies reached it within 30 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2018
First posted
Sep 27, 2018
StartActual
Oct 1, 2018
Primary completionEst.
Aug 1, 2020
CompletionEst.
Sep 1, 2020
Last update
Jul 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03687398
Responsible party
Sponsor
First posted
Sep 27, 2018
Start date
Oct 1, 2018
Primary completion
Aug 1, 2020 (estimated)
Completion
Sep 1, 2020 (estimated)
Last update
Jul 9, 2019

Study contacts

Bahar Yuksel, md
Contact
baharyl86@gmail.com
05424732003
ercan bastu, md
Contact
ercanbastu@gmail.com
Bahar Yuksel
study director · md

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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