The Role of Galectins in the Non-invasive Diagnosis of Endometriosis
The Role of Galectin-1,3,9 in the the Non-invasive Diagnosis of Endometriosis
1 other identifier
observational
1,000
0 countries
N/A
Brief Summary
Endometriosis is one of the most common infertility-related gynecologic disorder that affect approximately 10-15% of women in reproductive age. The main symptoms are chronic pelvic pain, infertility, dysmenorrhea and dyspareunia. There exists an average diagnostic delay of 7 year but data widely varies between different countries. The current "gold standard" in the diagnosis of endometriosis remains a laparoscopy. Since laparoscopy is an invasive surgical procedure with its potential risk, the development of a non-invasive laboratory test would be of great benefit in the early, clinical management of this diseaseIn the past few years, lectins have become the focus of reproductive immunology, inflammation and autoimmunity. Galectins (Gal) are beta-galactoside binding lectins that play a key role in the regulation of the immune system, cell growth, adhesion, apoptosis, and angiogenesis. Until now 13 different types of galectins have been found in humans, among them Gal-1-4, 7-9 and 12 were detected in the normal endometrium. So far only Gal-1 and Gal-3 have been studied in relation to endometriosis. In a recent pilot study, the investigators have shown that Gal-9 levels are significantly elevated in the serum of endometriosis patients compared to healthy controls. Gal-9 had a high sensitivity (94%) and specificity (93,75%), indicating better diagnostic potential than that of other endometriosis biomarkers and of surgery as the current gold standard.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Longer than P75 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2020
CompletedFirst Posted
Study publicly available on registry
May 26, 2020
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedApril 15, 2021
May 1, 2020
1 year
May 20, 2020
April 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of new non-invasive biomarker for endometriosis
24 months
Study Arms (1)
disease and control
Eligibility Criteria
in reproductive age laporoscopically proved endometriosis
You may qualify if:
- Histologically proved endometriosis
You may not qualify if:
- Previous or current hormone therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Semmelweis Universitylead
- University of Pecscollaborator
Related Publications (1)
Brubel R, Bokor A, Pohl A, Schilli GK, Szereday L, Bacher-Szamuel R, Rigo J Jr, Polgar B. Serum galectin-9 as a noninvasive biomarker for the detection of endometriosis and pelvic pain or infertility-related gynecologic disorders. Fertil Steril. 2017 Dec;108(6):1016-1025.e2. doi: 10.1016/j.fertnstert.2017.09.008.
PMID: 29202955BACKGROUND
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
May 20, 2020
First Posted
May 26, 2020
Study Start
September 1, 2021
Primary Completion
September 1, 2022
Study Completion
September 1, 2025
Last Updated
April 15, 2021
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share