Clinical trial NCT06214260: Menstrual Blood Proteomic Profile in Women With Endometriosis (PROTEO-ENDO) Study
Official title: Proteomic Profile in Women With Endometriosis (PROTEO-ENDO) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Endometriosis Ovary
Endometriosis-related Pain
Keywords: Endometriosis
Menstrual blood
Proteomics
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Menstrual blood plasma proteomic profile using Liquid chromatography-mass spectrometry (LC-MS/MS)
timeFrame: 24 months
Secondary outcomes:
measure: Determination of menstrual blood plasma proteomic profile in endometriosis phenotypes using an LC-MS/MS
timeFrame: 24 months
measure: Menstrual blood plasma proteomic profile in early (stage I/II) and Advance (stage III/IV) stage of endometriosis
timeFrame: 24 months
measure: Comparing the plasma of menstrual and peripheral blood proteomic profile using LC-MS/MS
timeFrame: 24 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong, Prince of Wales Hospital
Study officials:
References: