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Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Endometriosis

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ClinicalTrials.gov Identifier: NCT03020108
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Tracking Information
First Submitted Date January 11, 2017
First Posted Date January 13, 2017
Last Update Posted Date August 28, 2017
Study Start Date August 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 12, 2017)
To determine endometriosis severity with serum markers [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 12, 2017)
To determine rectal involvement with serum markers [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Endometriosis
Official Title The Relation Between Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Severity of Endometriosis
Brief 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. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum analysis
Sampling Method Non-Probability Sample
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.
Condition
  • Endometriosis
  • Apoptotic Pathway Deregulation
Intervention Other: Blood sample
2 cc blood samples will be drawn from antecubital vein
Other Name: Serum caspase 3, annexin a2 and soluble fas levels
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Other: Blood sample
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 12, 2017)
90
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The women with malignant diseases, chronic bowel disease, other defined cause of infertility.
Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03020108
Other Study ID Numbers 2016/190
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: To be shared with other researchers after all the data is available
Responsible Party Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study Sponsor Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Cihan Kaya, M.D. Bakırkoy Dr. Sadi Konuk Training and Research Hospital
PRS Account Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Verification Date August 2017