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

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

Study Description

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.

Condition or disease	Intervention/treatment
Endometriosis; Apoptotic Pathway Deregulation	Other: Blood sample

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

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Relation Between Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Severity of Endometriosis
• Study Start Date: August 2016
• Actual Primary Completion Date: June 2017
• Actual Study Completion Date: August 2017

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Other: Blood sample; 2 cc blood samples will be drawn from antecubital vein; Other Name: Serum caspase 3, annexin a2 and soluble fas levels
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.	Other: Blood sample; 2 cc blood samples will be drawn from antecubital vein; Other Name: Serum caspase 3, annexin a2 and soluble fas levels
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.	Other: Blood sample; 2 cc blood samples will be drawn from antecubital vein; Other Name: Serum caspase 3, annexin a2 and soluble fas levels

Outcome Measures

Primary Outcome Measures :

1. To determine endometriosis severity with serum markers [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. To determine rectal involvement with serum markers [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA

Serum analysis

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 55 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Locations

Turkey

Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Istanbul, Turkey, 34250

Sponsors and Collaborators

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

• Principal Investigator: Cihan Kaya, M.D.; Bakırkoy Dr. Sadi Konuk Training and Research Hospital

More Information

Additional Information:

PUBMED 

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.

• Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• ClinicalTrials.gov Identifier: NCT03020108
• Other Study ID Numbers: 2016/190
• First Posted: January 13, 2017
• Last Update Posted: August 28, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: To be shared with other researchers after all the data is available

Additional relevant MeSH terms:

Endometriosis