- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07164196
- Original Trial
Endometriosis-Angiopoietin-like Protein-4
September 2, 2025 updated by: Merve Didem Eşkin Tanrıverdi, Ankara City Hospital Bilkent
Evaluation of Angiopoietin-like Protein 4 Levels in Patients With Endometriosis
Endometriosis is a chronic inflammatory disease associated with pelvic pain, dyspareunia, and impaired ovarian reserve.
Cancer antigen-125 (CA-125) is widely studied but limited by low specificity, while angiopoietin-like protein-4 (ANGPTL4) has emerged as a potential biomarker due to its role in angiogenesis and inflammation.
In the current study it was aimed to investigate serum and peritoneal fluid ANGPTL4 levels in women with endometriosis compared to healthy controls, and to evaluate their associations with clinical symptoms, serum CA-125, and anti-Müllerian hormone levels.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Not Valid
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Ankara, Not Valid, Turkey (Türkiye), 06100
- Ankara Bilkent City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Study population includes a total of 80 participants.
The study group consists of 40 women with the diagnosis of endometriosis, and the control group consists of 40 healthy women.
Description
Inclusion Criteria:
- Diagnosis of endometriosis for study group who underwent laparoscopic endometriosis surgery
- Healthy women for control group
Exclusion Criteria:
- Cardiovascular diseases including hypertension
- Type 1 or type 2 diabetes mellitus
- Morbid obesity
- Primary adrenal insufficiency
- Uterine fibroids
- Thyroid dysfunctions including Hashimoto thyroiditis and Grave's disease
- Hepatic dysfunctions
- Renal insufficiency
- Genetic disorders in chromosome constitution or karyotype analysis including monosomy X, trisomy X and gene mutations as BMP15, FMR I, POFIB, and GDF9
- Neurologic diseases
- Psychiatric disorders
- Autoimmune diseases or syndromes including Addison's disease, autoimmune syndromes, scleroderma, Sjogren's syndrome, myasthenia gravis, inflammatory bowel diseases, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and familial Mediterranean fever
- History of any malignancy
- History of exposure to chemotherapeutic agents or radiotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Endometriosis group (Study group)
The study group included women with endometriosis.
The study group consisted of women diagnosed with endometriosis who consecutively underwent laparoscopic endometriosis surgery.
|
Measurement of peritoneal fluid levels of Angiopoietin-like protein-4 (ANGPTL4) level by ELISA method.
Measurement of venous blood serum level of CA-125 level by ELISA method.
Measurement of venous blood serum level of Angiopoietin-like protein-4 (ANGPTL4) Level level by ELISA method.
|
|
Healthy women (Control group)
Control group consisted of healthy women.
The control group consisted of women who consecutively visited the outpatient clinic for routine gynecologic examinations and had no known diseases.
|
Measurement of venous blood serum level of CA-125 level by ELISA method.
Measurement of venous blood serum level of Angiopoietin-like protein-4 (ANGPTL4) Level level by ELISA method.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum and peritoneal fluid Angiopoietin-like protein-4 level
Time Frame: day 1
|
Nanogram/milliliter
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum cancer antigen 125 level
Time Frame: day 1
|
Unit/milliliter
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Merve Didem Eşkin Tanrıverdi, MD, Ankara City Hospital Bilkent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469.
- Campara K, Rodrigues P, Viero FT, da Silva B, Trevisan G. A systematic review and meta-analysis of advanced oxidative protein products levels (AOPP) levels in endometriosis: Association with disease stage and clinical implications. Eur J Pharmacol. 2025 Jun 5;996:177434. doi: 10.1016/j.ejphar.2025.177434. Epub 2025 Feb 28.
- Makoui MH, Fekri S, Makoui RH, Ansari N, Esmaeilzadeh A. The Role of Mast Cells in the Development and Advancement of Endometriosis. Am J Reprod Immunol. 2025 Mar;93(3):e70019. doi: 10.1111/aji.70019.
- Brown R, Imran SA, Wilkinson M. Lipopolysaccharide (LPS) stimulates adipokine and socs3 gene expression in mouse brain and pituitary gland in vivo, and in N-1 hypothalamic neurons in vitro. J Neuroimmunol. 2009 Apr 30;209(1-2):96-103. doi: 10.1016/j.jneuroim.2009.02.001. Epub 2009 Mar 3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2025
Primary Completion (Actual)
August 21, 2025
Study Completion (Actual)
September 2, 2025
Study Registration Dates
First Submitted
September 2, 2025
First Submitted That Met QC Criteria
September 2, 2025
First Posted (Estimated)
September 10, 2025
Study Record Updates
Last Update Posted (Estimated)
September 10, 2025
Last Update Submitted That Met QC Criteria
September 2, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pain
- Neurologic Manifestations
- Pathologic Processes
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Inflammation
- Endometriosis
- Pelvic Pain
- Peptides
- Amino Acids, Peptides, and Proteins
- Proteins
- Biological Factors
- Carbohydrates
- Intercellular Signaling Peptides and Proteins
- Glycoproteins
- Glycoconjugates
- Antigens
- Antigens, Tumor-Associated, Carbohydrate
- Antigens, Neoplasm
- Epitopes
- Biomarkers, Tumor
- Biomarkers
- Angiopoietin-like Proteins
- Angiogenic Proteins
- Mucins
- Mucoproteins
- Angiopoietin-Like Protein 4
- CA-125 Antigen
Other Study ID Numbers
- TABED 1-25-1372
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD are available which may be shared in necessary conditions.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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