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

Not Applicable

Active, not recruiting

• Conditions: Endometriosis
• Interventions: Procedure: 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis; Procedure: women with intraoperative and / or histopathology findings suggestive of endometriosis

• Registration Number: NCT06168097
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-10-21
• Study Start: 2023-11-15
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-10
• Last Update Submitted: 2023-12-10
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13
• Primary Completion: 2026-12-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis	100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis	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.
100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis	women with intraoperative and / or histopathology findings suggestive of endometriosis	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.

Primary Outcome Measures

Name	Time	Method
2. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways	3 years	ROC curve analysis is to estimate the sensitivity and specificity of miRNA expression levels to establish them as biomarkers for endometriosis.

Secondary Outcome Measures

Name	Time	Method
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	Western Blot and immunohistochemical analysis (IHC) for expression analysis..

Trial Locations

Locations (1)

Shraddha Ramchandani; 🇮🇳 Hyderabad, Telanagana, India