NCT06214260

Brief Summary

In this prospective case control study a total of 66 women (33 women with endometriosis) and (33 healthy women) will be recruited. The main objective of the study is to investigate the proteomic profile of menstrual blood in women with endometriosis compared to controls. Additionally, differentially expressed proteins will be investigated across different stages, clinical presentations, and subtypes of endometriosis

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 10, 2024

Last Update Submit

January 18, 2024

Conditions

EndometriosisEndometriosis OvaryEndometriosis-related Pain

Keywords

EndometriosisMenstrual bloodProteomics

Outcome Measures

Primary Outcomes (1)

  • Menstrual blood plasma proteomic profile using Liquid chromatography-mass spectrometry (LC-MS/MS)

    A functional proteomic assay will be employed to separate a protein to identify the putative novel biomarkers of endometriosis using shotgun proteomics with mass spectrometry. Both expression and functional proteomics will be investigated in women with endometriosis, and controls. A bottom-up proteomics approach will be implemented through steps such as extraction of proteins from a sample, digestion of proteins into peptides, post-digestion separations, and analysis

    24 months

Secondary Outcomes (3)

  • Determination of menstrual blood plasma proteomic profile in endometriosis phenotypes using an LC-MS/MS

    24 months

  • Menstrual blood plasma proteomic profile in early (stage I/II) and Advance (stage III/IV) stage of endometriosis

    24 months

  • Comparing the plasma of menstrual and peripheral blood proteomic profile using LC-MS/MS

    24 months

Study Arms (2)

Endometriosis

Women suggested endometriosis by clinical presentations \& imaging and scheduled for surgical treatment (laparotomy/laparoscopy) at the age of 18-45 years having regular menstrual cycles will be recruited. Finally laparoscopy and histology confirmed endometriosis cases will be eligible for the final analysis.

Diagnostic Test: Peripheral blood sampleDiagnostic Test: Menstrual Blood sample

Healthy groups

Control subjects at the age of 18-45 years, who have regular menstrual cycles and self-reported no history suggestive of a diagnosis of endometriosis will be recruited.

Diagnostic Test: Peripheral blood sampleDiagnostic Test: Menstrual Blood sample

Interventions

Peripheral blood sampleDIAGNOSTIC_TEST

Peripheral blood will be collected with a 10 ml Ethylenediaminetetra acetic acid (EDTA) tube before surgery during menstrual phase. Additionally, participants will be asked with an interview on demographic, surgical, medical, obstetric, gynecological, contraceptive and medication use history which is validated by Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project (WERF EPHect). Pain symptoms before surgery will be evaluated through a 10 cm long one-dimensional visual-analogue scale (VAS).

EndometriosisHealthy groups
Menstrual Blood sampleDIAGNOSTIC_TEST

5ml menstrual blood will be collected before surgery by the women herself. Additionally, participants will be asked with an interview on demographic, surgical, medical, obstetric, gynecological, contraceptive and medication use history which is validated by Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project (WERF EPHect). Pain symptoms before surgery will be evaluated through a 10 cm long one-dimensional visual-analogue scale (VAS).

EndometriosisHealthy groups

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGiven that this study aims to collect menstrual blood and examine differentially expressed proteins, solely individuals of the female gender are deemed eligible
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Endometriosis group: Patients referred to Obstetrics and Gynaecology specialty outpatient clinic by clinicians for the diagnosis of endometriosis, and/or treatment, or for pelvic pain investigation, and agreed to undergo for laparoscopic surgery for the investigation and/or treatment of endometriosis, or pelvic pain will be recruited. Healthy groups: Women who have self-reported that they do not have any known medical, surgical, or gynecological conditions.

You may qualify if:

  • Endometriosis group. are women aged 18-45 years old Laparoscopy with histologically confirmed diagnosis of endometriosis
  • Healthy group are women between 18-45 years old self reported no known history of medical \& surgical diseases and no any sign of endometriosis related symptoms

You may not qualify if:

  • Endometriosis group
  • Hormonal treatment in the past three months before surgery,
  • Previous and current malignancy
  • Having history of autoimmune disease
  • Having previous surgery due to endometriosis
  • Pelvic inflammatory disease (PID)
  • Lactating/breastfeeding women
  • Adenomyosis
  • Polycystic ovarian syndrome (PCOS)
  • History of or currently on traditional Chinese medicine
  • \- Healthy group
  • Hormonal treatment in the past three months before surgery,
  • Previous and current malignancy
  • Having history of autoimmune disease
  • Having previous surgery due to endometriosis
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma will be isolated from both peripheral and menstrual blood.

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chi Chiu Wang, MD, PhD

CONTACT

(852) 35054267ccwang@cuhk.edu.hk

Getnet Gedefaw Azeze, MSc

CONTACT

(852) 51724303gedefawget@link.cuhk.edu.hk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Division head of Obstetrics and Gynaecology

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 19, 2024

Study Start

November 15, 2023

Primary Completion

November 15, 2025

Study Completion

February 15, 2026

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Individual participant data will be available as a supplementary file in publications. It will be available to anyone up on the official request from the principal investigator

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Two year after initiation of the study
Access Criteria
official request and memorandum of understanding signing

Locations

HK(1)