Menstrual Blood Proteomic Profile in Women With Endometriosis (PROTEO-ENDO) Study

Endometriosis Clinical Trial

— PROTEO-ENDO  

Official title:

Proteomic Profile in Women With Endometriosis (PROTEO-ENDO) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214260
• Other study ID #: PROTEO-ENDO 20230313
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: February 15, 2026

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: Chi Chiu Wang, MD, PhD
• Phone: (852) 35054267
• Email: ccwang[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Endometriosis is a disease characterized by the growth of endometrium like tissue outside the uterus. It is the most common and complex gynecological complications in reproductive age woman and schoolgirls. Though the exact etiology of endometriosis is unknown, and the incidence is varying among age and women with infertility, however, it ranges from 2% to 10% within the general female population, estimating around 190 million women at reproductive age and schoolgirls globally and up to 50% in infertile women. The variable, non-specific and broad symptoms of endometriosis lead the clinicians not to easily diagnose the disease and it causes a lengthy delay between the onset of symptoms and confirmation of diagnosis. To date, there is no known non-invasive diagnostic method for endometriosis and no known cure for endometriosis, and treatment is usually aimed at controlling symptoms. New noninvasive non-imaging diagnostic methods, such as biomarkers in serum/blood, and urine have been proposed. However, a definitive diagnosis biomarker is not available yet. Despite the range of blood tests that have been investigated, and altered levels of cancer antigen (CA-125), cytokines, angiogenic, and growth factors, none of the biomarkers showed the definitive diagnosis of endometriosis. Hence this prospective case control study aims to explore non-invasive diagnostic biomarkers from menstrual blood and establish pathophysiology mechanism of the disease. This study is undergoing based on the Helsinki Declaration Guideline for Good Clinical Practice (GCP) standards. Ethical approval is obtained from the Joint Chinese University of Hong Kong and New Territories East Cluster (CUHK-NTEC) Clinical Research Ethics Committee, Hong Kong with reference number: 2023.126.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: February 15, 2026
• Est. primary completion date: November 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

• Pelvic inflammatory disease (PID)

• Lactating/breastfeeding women

• Adenomyosis

• Polycystic ovarian syndrome (PCOS)

• History of or currently on traditional Chinese medicine

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis Ovary
• Endometriosis-related Pain

Intervention

Diagnostic Test:
• Peripheral blood sample
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).
• Menstrual Blood sample
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).

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determination of menstrual blood plasma proteomic profile in endometriosis phenotypes using an LC-MS/MS	Investigators expect that women in the endometriosis group will differ with regard to proteomic profile with respect to the disease phenotype different phenotypes of the disease: peritoneal endometriosis, ovarian endometriosis, deep infiltrating endometriosis	24 months
Secondary	Menstrual blood plasma proteomic profile in early (stage I/II) and Advance (stage III/IV) stage of endometriosis	According to the revised American society of reproductive medicine (rASRM) endometriosis is categorized in to four stages. The protein expression of each stages of endometriosis will be compared with the bottom-up approach proteomics study using LC-MS/MS	24 months
Secondary	Comparing the plasma of menstrual and peripheral blood proteomic profile using LC-MS/MS	As the composition of menstrual blood is heterogeneous and complex, investigators expect the expressed proteins from the peripheral blood plasma will differ from the expressed proteins of menstrual blood.	24 months