NCT05312528

Brief Summary

The diagnostic value of Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and Proinflammatory cytokines (TNF-a and interleukin-6) in ovarian endometriosis and deep infiltrating endometriosis, their levels in organ-specific involvement, their relationship with symptoms, and the changes of these markers in the postoperative period will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

February 23, 2022

Last Update Submit

March 26, 2022

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (6)

  • Diagnostic value of serum Annexin V in endometriosis

    To determine whether serum Annexin V levels (ng/mL) can be used as diagnostic markers of endometriosis disease.

    Up to 4 months

  • Diagnostic value of serum sVCAM-1 in endometriosis

    To determine whether serum sVCAM-1(ng/mL) levels can be used as diagnostic markers of endometriosis disease.

    Up to 4 months

  • Diagnostic value of serum sICAM-1 in endometriosis

    To determine whether serum sICAM-1(ng/mL) levels can be used as diagnostic markers of endometriosis disease.

    Up to 4 months

  • Diagnostic value of serum Vascular Endothelial Growth Factor in endometriosis

    To determine whether serum Vascular Endothelial Growth Factor (pg/mL) levels can be used as diagnostic markers of endometriosis disease.

    Up to 4 months

  • Diagnostic value of serum TNF-alpha in endometriosis

    To determine whether serum TNF-alpha (pg/mL) levels can be used as diagnostic markers of endometriosis disease.

    Up to 4 months

  • Diagnostic value of serum Interleukin-6 in endometriosis

    To determine whether serum Interleukin-6 (pg/mL) levels can be used as diagnostic markers of endometriosis disease.

    Up to 4 months

Study Arms (2)

Study Group

Stage 3 and 4 endometriosis patients

Procedure: endometriosis surgery

Control Group

Patients without endometriosis, who required surgery for tubal ligation, benign ovarian cysts or uterine fibroids were included.

Procedure: other benign condition surgeries

Interventions

endometriosis surgeryPROCEDURE

Laparoscopy was performed in the follicular phase of the woman's menstrual cycle and all recognizable endometriotic lesions were treated by bipolar coagulation, resection of endometriotic nodules and ovarian cystectomy.

Study Group
other benign condition surgeriesPROCEDURE

ovarian cystectomy, bilateral tubal ligation, myomectomy etc.

Control Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Stage III and IV endometriosis patients aged 18-50 years requiring surgery for chronic pelvic pain or suspected malignancy

You may qualify if:

  • \. Stage III and IV endometriosis patients requiring surgery due to chronic pelvic pain or suspected malignancy

You may not qualify if:

  • Malignant disease
  • Ovarian failure
  • Acute pelvic inflammatory disease
  • Smokers
  • Pregnancy
  • Chronic autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Teaching and Research Hospital

Istanbul, Bagcilar, 34200, Turkey (Türkiye)

Location

Related Publications (1)

  • Vodolazkaia A, El-Aalamat Y, Popovic D, Mihalyi A, Bossuyt X, Kyama CM, Fassbender A, Bokor A, Schols D, Huskens D, Meuleman C, Peeraer K, Tomassetti C, Gevaert O, Waelkens E, Kasran A, De Moor B, D'Hooghe TM. Evaluation of a panel of 28 biomarkers for the non-invasive diagnosis of endometriosis. Hum Reprod. 2012 Sep;27(9):2698-711. doi: 10.1093/humrep/des234. Epub 2012 Jun 26.

    PMID: 22736326RESULT

Related Links

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Evrim Ebru Kovalak, MD

    Bagcilar Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Obstetrician and Gynecologist

Study Record Dates

First Submitted

February 23, 2022

First Posted

April 5, 2022

Study Start

February 1, 2018

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

April 5, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)