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Trial record 3 of 11 for:    ANXA2

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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




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


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020108


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

Additional Information:
PUBMED  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT03020108     History of Changes
Other Study ID Numbers: 2016/190
First Posted: January 13, 2017    Key Record Dates
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:
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Endometriosis
Genital Diseases, Female