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

NCT03020108 | Completed

• 1 other identifier: 2016/190
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Apoptotic Pathway Deregulation

Outcome Measures

Primary Outcomes (1)

• To determine endometriosis severity with serum markers

  1 year

Secondary Outcomes (1)

• To determine rectal involvement with serum markers

  1 year

Study Arms (3)

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

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

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

Interventions

Blood sample OTHER

2 cc blood samples will be drawn from antecubital vein

Also known as: Serum caspase 3, annexin a2 and soluble fas levels

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• The women with malignant diseases, chronic bowel disease, other defined cause of infertility.

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

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

Istanbul, 34250, Turkey (Türkiye)

Location

Related 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.

  PMID: 25943872 BACKGROUND

Related Links

• PUBMED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum analysis

MeSH Terms

Conditions

Endometriosis

Interventions

Blood Specimen Collection; Annexin A2

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Annexins; Calcium-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Cihan Kaya, M.D.

  Bakırkoy Dr. Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 28, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)