The Use of MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis

N/AActive Not RecruitingNCT06168097

Asian Institute of Gastroenterology, India200 enrolled

Overview

OBJECTIVES : 1. 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. 2. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways. 3. Evaluation of significant outcome of objective 1 in serum samples to establish them as biomarkers. Study Design: Case control study. sample size: 200

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Endometriosis

Interventions

100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosisPROCEDURE

1. We Will take Both blood and tissue samples used to study them. 2. We 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.

women with intraoperative and / or histopathology findings suggestive of endometriosisPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

ROC curve analysis is to estimate the sensitivity and specificity of miRNA expression levels to establish them as biomarkers for endometriosis.

Time frame: 3 years

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)

Western Blot and immunohistochemical analysis (IHC) for expression analysis..