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

Endometriosis Clinical Trial

Official title:

The Relation Between Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Severity of Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020108
• Other study ID #: 2016/190
• Status: Completed
• Phase: N/A
• First received: January 11, 2017
• Last updated: August 24, 2017
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The blood samples will be drawn for analysis of serum biomarkers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apoptotic Pathway Deregulation
• Endometriosis

Intervention

Other:
• Blood sample
2 cc blood samples will be drawn from antecubital vein

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine endometriosis severity with serum markers		1 year
Secondary	To determine rectal involvement with serum markers		1 year

External Links

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