跳至主要内容
临床试验/NCT06214260
NCT06214260招募中不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
66
试验地点
1
主要终点
Menstrual blood plasma proteomic profile using Liquid chromatography-mass spectrometry (LC-MS/MS)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 24 months

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

次要结局

  • Menstrual blood plasma proteomic profile in early (stage I/II) and Advance (stage III/IV) stage of endometriosis(24 months)
  • Determination of menstrual blood plasma proteomic profile in endometriosis phenotypes using an LC-MS/MS(24 months)
  • Comparing the plasma of menstrual and peripheral blood proteomic profile using LC-MS/MS(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ronald Wang

Professor & Division head of Obstetrics and Gynaecology

Chinese University of Hong Kong

研究点 (1)

Loading locations...

相似试验