Biomarkers in Endometriosis

• ClinicalTrials.gov Identifier: NCT04591548
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Last Update Posted: April 27, 2021
• Sponsor: University Medical Centre Ljubljana
• Collaborator: University of Ljubljana
• Information provided by (Responsible Party): Vid Jansa, University Medical Centre Ljubljana

Study Description

Brief Summary:

Endometriosis is a common gynecological benign disease which significantly compromise quality of life in patients and is a major cofactor of infertility. With the proteomic approach the investigators will search for proteins with significantly different levels in peritoneal fluid, serum and uterine fluid samples of women with endometriosis versus control group. Results will be validate using ELISA aproach.

Condition or disease	Intervention/treatment
Endometriosis	Diagnostic Test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample

Detailed Description:

Informed consent will be obtained from all individual participants included in the study. Blood sample will be obtained the day before laparoscopic surgery during regular clinical preoperative procedures. Peritoneal fluid and uterine fluid will be obtained during regular laparoscopic procedure indicated for infertility, the exact protocol of sample obtaining will be revealed after publication of results. The aim of the study was to identify potential diagnostic and predictive biomarkers or drug targets.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Target Follow-Up Duration: 1 Day
• Official Title: Biomarkers in Endometriosis
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: January 1, 2020
• Actual Study Completion Date: January 1, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Endometriosis; All patients had laparoscopy due to infertility (and endometriosis). All women had BMI in normal range and regular menstrual cycle (21-35 days). Partner's semen analysis was normal in all cases. The investigators excluded patients with hormonal therapy in the last year, irregular menstrual cycle, smokers and patients with autoimmune diseases, malignant or suspected malignant diseases, previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries. None of the patients had previous pelvic surgery.	Diagnostic Test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample; All samples were collected during laparoscopy, before any intraabdominal procedure was done. Indication for surgery was clinical (not for research purpose). All sample collection procedures was mimic regular clinical procedures.
Primary infertility; All patients had laparoscopy due to infertility (and endometriosis). All women had BMI in normal range and regular menstrual cycle (21-35 days). Partner's semen analysis was normal in all cases. The investigators excluded patients with hormonal therapy in the last year, irregular menstrual cycle, smokers and patients with autoimmune diseases, malignant or suspected malignant diseases, previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries. None of the patients had previous pelvic surgery.	Diagnostic Test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample; All samples were collected during laparoscopy, before any intraabdominal procedure was done. Indication for surgery was clinical (not for research purpose). All sample collection procedures was mimic regular clinical procedures.

Outcome Measures

Primary Outcome Measures :

1. Derivation of the panel of proteins indicative of endometriosis using comparative proteomics [ Time Frame: 3 years to collect all speciments ]
   The aim of the study is to identify proteins with different levels in cases versus controls these proteins could be new candidates for biomarkers of endometriosis. Differentially expressed proteins are candidates for diagnostic and predictive biomarkers. To identify differentially expresed proteins in discovery phase of the study proteomic aproach will be used.

Secondary Outcome Measures :

1. Concentrations of proteins in body fluids to validate the identified panel of proteins indicative of endometriosis [ Time Frame: 3 years to collect all speciments ]
   Using pairs of subjects with and without endometriosis, the derivation of the panel of proteins in body fluids (peritoneal fluid, peripheral blood, uterine fluid samples) gathered through proteomic aproach will be validated using ELISA.

Biospecimen Retention:   Samples Without DNA

peritoneal fluid precipitate, serum precipitate, uterine fluid precipitate

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Gynecological condition
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary infertility or endometriosis with clinical indication for surgery.

Criteria

Inclusion Criteria:

• primary infertility
• normal semen analysis of the partner
• normal BMI.

Exclusion Criteria:

• hormonal therapy in the last year,
• irregular menstrual cycle,
• previous pelvic surgery,
• history of previous pelvic inflammatory disease,
• smokers and patients with autoimmune diseases,
• malignant or suspected malignant diseases,
• previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries

Contacts and Locations

Sponsors and Collaborators

University Medical Centre Ljubljana

University of Ljubljana

Investigators

• Principal Investigator: Vid Jansa, MD; UKCLjubljana

More Information

• Responsible Party: Vid Jansa, Principal Investigator, University Medical Centre Ljubljana
• ClinicalTrials.gov Identifier: NCT04591548
• Other Study ID Numbers: BEND
• First Posted: October 19, 2020
• Last Update Posted: April 27, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vid Jansa, University Medical Centre Ljubljana:

Endometriosis; Biomarkers

Additional relevant MeSH terms:

Endometriosis