Clinical trial NCT03020108: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Apoptotic Pathway Deregulation
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2017-01-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: To determine endometriosis severity with serum markers
timeFrame: 1 year
Secondary outcomes:
measure: To determine rectal involvement with serum markers
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
Study officials:
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: Cihan Kaya, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.