MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- Asian Institute of Gastroenterology, India
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 2. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
OBJECTIVES :
- To investigate the expression pattern of miRNAs operational in inflammation, angiogenesis, hypoxia, apoptosis and cell proliferation in eutopic and ectopic endometrium of patients with endometriosis and normal endometrium of healthy controls.
- To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways.
- Evaluation of significant outcome of objective 1 in serum samples to establish them as biomarkers.
Study Design:
Case control study. sample size: 200
Detailed Description
METHODOLOGY : 1 Investigator will take Both blood and tissue samples used to study them. 2. Investigator will take approximately 3 ml of blood which will be used from the blood sample collected for routine preoperative tests (Surgical profile) before their planned surgery. 3.Small tissue samples will be taken from the tissue which is surgically excised as a part of treatment. 4. It will include tissue from inner lining of uterus (endometrium) in all participants and from excised endometriosis tissue in patients with endometriosis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients having more severe forms of endometriosis (Stage III and IV)
- •The probands were chosen randomly from the pool of available endometriosis patients and healthy controls of Indian origin.
Exclusion Criteria
- •Diagnosis of non-endometriotic ovarian cysts, adenomyosis, ovarian cancer, fibroids, and stage I and II endometriosis.
- •Exclusion criteria defined for the control group were personal history of chronic pelvic pain, secondary dysmenorrhea, abnormal uterine bleeding and family history of endometriosis.
Outcomes
Primary Outcomes
2. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways
Time Frame: 3 years
ROC curve analysis is to estimate the sensitivity and specificity of miRNA expression levels to establish them as biomarkers for endometriosis.
Secondary Outcomes
- To investigate the expression pattern of miRNAs and their downstream targets in endometrial tissues (samples of normal adult endometrium and ectopic and eutopic endometrium of patients with endometriosis)(3 years)