NCT06168097

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

MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2023-11-15
• Primary completion: 2026-12-15
• Completion: 2026-12-15
• First posted: 2023-12-13
• Last updated: 2023-12-13

Locations

1 site across 1 country: India