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Clinical Trials in India / NCT06168097
Active, not recruiting Not applicable

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

NCT06168097 · tracked via the Priya Life Science India tracker
Sponsor
Asian Institute of Gastroenterology, India
Phase
Not applicable
Started
2023-11-15
Last updated
2023-12-13

Condition(s) studied

Endometriosis

Investigational drug(s) / intervention(s)

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

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.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Shraddha Ramchandani Hyderabad Telanagana

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06168097 on ClinicalTrials.gov ↗ ← All trials in India