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

NCT ID: NCT03020108

Last Updated: 2017-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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

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Endometriosis Apoptotic Pathway Deregulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood sample

Intervention Type OTHER

2 cc blood samples will be drawn from antecubital vein

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.

Blood sample

Intervention Type OTHER

2 cc blood samples will be drawn from antecubital vein

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.

Blood sample

Intervention Type OTHER

2 cc blood samples will be drawn from antecubital vein

Interventions

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Blood sample

2 cc blood samples will be drawn from antecubital vein

Intervention Type OTHER

Other Intervention Names

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Serum caspase 3, annexin a2 and soluble fas levels

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cihan Kaya, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Locations

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

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25943872 (View on PubMed)

Other Identifiers

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2016/190

Identifier Type: -

Identifier Source: org_study_id

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