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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Endometriosis-related Pain; Endometriosis; Endometriosis Ovary

Treatments: Diagnostic Test: Menstrual Blood sample; Diagnostic Test: Peripheral blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT06214260

PROTEO-ENDO 20230313

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

66 participants in 2 patient groups

Endometriosis

Description:

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.

Treatment:

Diagnostic Test: Menstrual Blood sample

Diagnostic Test: Peripheral blood sample

Healthy groups

Description:

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.

Treatment:

Diagnostic Test: Menstrual Blood sample

Diagnostic Test: Peripheral blood sample