EndometriosisNCT03687398
Genomic Maps of Endometrial Tissues of Patients With Endometriosis and Healthy Controls
An observational study of Endometriosis and Endometrioma, run by Acibadem University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Endometrioma
- What is being tested?
- genetic testing with nanoclonal technique
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- being diagnosed with any kind of malignancy having trouble with endometrial cavity sampling
Trial locations and contacts
1 site in 1 country.
ercan bastu, md contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bahar Yuksel
Istanbul, 34104
Bahar Yuksel, 5424732003, baharyl86@gmail.com
About this study
Official title: Comparison of Genomic Maps of Endometrial Tissues of Patients With Endometriosis and Healthy Controls Via Nanochannel Technique and Proteomic-genomic Analyzes.
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.
- Conditions
- Endometriosis, Endometrioma
- Being tested
- genetic testing with nanoclonal technique
- Keywords
- genetic analysis, endometriosis, nanoclonal, copy number
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic testing with nanoclonal techniqueDiagnostic test
endometrial sampling
| Study group | Role | What they receive |
|---|---|---|
| control | does not have endometriosis or related diseases and not under any drug therapy does not have any benign or malign disease Receives: Diagnostic Test: genetic testing with nanoclonal technique | |
| patient | has laparoscopically proven endometriosis Receives: Diagnostic Test: genetic testing with nanoclonal technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Oct 2018
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bahar Yuksel, Study director, md
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687398
- Sponsor's protocol ID
- AcibademU endo
- Status last verified
- Jul 2019
- First submitted
- 16 Sep 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 25671094Kobayashi 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Genomic Maps of Endometrial Tissues of Patients With Endometriosis and Healthy Controls Via Nanochannel Technique and Proteomic-genomic Analyzes.
- ClinicalTrials.gov ID
- NCT03687398
- Acronym / sponsor ID
- AcibademU endo
- Conditions
- Endometriosis, Endometrioma
- Keywords
- genetic analysis, endometriosis, nanoclonal, copy number
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Diagnostic Test: genetic testing with nanoclonal techniquedoes not have endometriosis or related diseases and not under any drug therapy does not have any benign or malign disease |
| patient | – | Diagnostic Test: genetic testing with nanoclonal techniquehas laparoscopically proven endometriosis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- being diagnosed with any kind of malignancy having trouble with endometrial cavity sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic testing with nanoclonal techniqueendometrial sampling | Diagnostic test | control, patient |
Primary outcome
diagnostic testing
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Results publication: PubMed 25671094Cao 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.
- Results publication: PubMed 24639062Kobayashi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ercan bastu, md contact
Bahar Yuksel study director
md
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Endometrioma, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahar Yuksel, md (05424732003, baharyl86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic testing (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03687398, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.