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

NCT06168097 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-12-13

No results posted yet for this study

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

Conditions

  • Endometriosis

Interventions

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.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Shraddha Ramchandani · Asian Institute of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2026-12-15
Completion
2026-12-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168097 on ClinicalTrials.gov