EndometriosisNCT03020108
Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Endometriosis
An observational study of Endometriosis and Apoptotic Pathway Deregulation, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study population will comprise of 90 women age varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility. Read more about this study
- Who is it for?
- Ages 15 to 55 years, women only
- Conditions the study is for
- Endometriosis, Apoptotic Pathway Deregulation
- What is being tested?
- Blood sample
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2016to Aug 2017
- 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 15 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The study population will comprise of women age varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility.
Who may be able to join
- The women ages varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility.
Who cannot join
- The women with malignant diseases, chronic bowel disease, other defined cause of infertility.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
Istanbul, 34250
About this study
Official title: The Relation Between Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Severity of Endometriosis
The study population will comprise of 90 women age varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility. The blood samples will be drawn for analysis of serum biomarkers.
Read the detailed description
The participants will be accepted for the study between 1st of August 2016 to 30th June 2017. 2 cc blood samples will be drawn from the antecubital vein for serum analysis of caspase 3, annexin a2 and soluble fas levels before the operations. The patients will divide into three groups. The group 1 will comprise of 30 patients with benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination. The group 2 will comprise of 30 patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. The group 3 will comprise of 30 patients with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. The blood samples will be kept in -80 C degree after centrifuge till at the end of the study.The relation between serum caspase 3, annexin a2 and soluble fas levels and severity of endometriosis will be analysed.
- Conditions
- Endometriosis, Apoptotic Pathway Deregulation
- Being tested
- Blood sample
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Also called Serum caspase 3, annexin a2 and soluble fas levels
2 cc blood samples will be drawn from antecubital vein
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The group 1 will comprise of 30 patients with benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination. Receives: Other: Blood sample | |
| Group 2 | The group 2 will comprise of 30 patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. Receives: Other: Blood sample | |
| Group 3 | The group 3 will comprise of 30 patients with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine endometriosis severity with serum markers
Measured: 1 year
Secondary outcomes (1)
To determine rectal involvement with serum markers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cihan Kaya, M.D., Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020108
- Sponsor's protocol ID
- 2016/190
- Status last verified
- Aug 2017
- First submitted
- 11 Jan 2017
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: To be shared with other researchers after all the data is available
Publications
Flood B, Oficjalska K, Laukens D, Fay J, O'Grady A, Caiazza F, Heetun Z, Mills KH, Sheahan K, Ryan EJ, Doherty GA, Kay E, Creagh EM. Altered expression of caspases-4 and -5 during inflammatory bowel disease and colorectal cancer: Diagnostic and therapeutic potential. Clin Exp Immunol. 2015 Jul;181(1):39-50. doi: 10.1111/cei.12617. Epub 2015 May 6.
PubMed 25943872
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Severity of Endometriosis
- ClinicalTrials.gov ID
- NCT03020108
- Acronym / sponsor ID
- 2016/190
- Conditions
- Endometriosis, Apoptotic Pathway Deregulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- 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.
The study population will comprise of 90 women age varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility. The blood samples will be drawn for analysis of serum biomarkers.
Detailed description
The participants will be accepted for the study between 1st of August 2016 to 30th June 2017. 2 cc blood samples will be drawn from the antecubital vein for serum analysis of caspase 3, annexin a2 and soluble fas levels before the operations. The patients will divide into three groups. The group 1 will comprise of 30 patients with benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination. The group 2 will comprise of 30 patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. The group 3 will comprise of 30 patients with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. The blood samples will be kept in -80 C degree after centrifuge till at the end of the study.The relation between serum caspase 3, annexin a2 and soluble fas levels and severity of endometriosis will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Blood sampleThe group 1 will comprise of 30 patients with benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination. |
| Group 2 | – | Other: Blood sampleThe group 2 will comprise of 30 patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. |
| Group 3 | – | Other: Blood sampleThe group 3 will comprise of 30 patients with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will comprise of women age varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility.
Key inclusion criteria (1 listed)
- The women ages varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility.
Key exclusion criteria (1 listed)
- The women with malignant diseases, chronic bowel disease, other defined cause of infertility.
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 |
|---|---|---|
| Blood sampleAlso: Serum caspase 3, annexin a2 and soluble fas levels2 cc blood samples will be drawn from antecubital vein | Other | Group 1, Group 2, Group 3 |
Primary outcome
To determine endometriosis severity with serum markers
Time frame: 1 year
1 secondary outcome
To determine rectal involvement with serum markers
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Background: PubMed 25943872Flood B, Oficjalska K, Laukens D, Fay J, O'Grady A, Caiazza F, Heetun Z, Mills KH, Sheahan K, Ryan EJ, Doherty GA, Kay E, Creagh EM. Altered expression of caspases-4 and -5 during inflammatory bowel disease and colorectal cancer: Diagnostic and therapeutic potential. Clin Exp Immunol. 2015 Jul;181(1):39-50. doi: 10.1111/cei.12617. Epub 2015 May 6.
- PUBMEDLink provided by the sponsor.
- Individual participant dataSharing planned: No. To be shared with other researchers after all the data is available
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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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.
Cihan Kaya, M.D. principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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 Apoptotic Pathway Deregulation, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 1 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: finished, as of the sponsor's last update on 28 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine endometriosis severity with serum markers (time frame: 1 year). 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 NCT03020108, which also lists 1 linked publication.
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 28 Aug 2017.