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

Endometriosis Clinical Trial

— ENDMET  

Official title:

MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06168097
• Other study ID #: Endometriosis-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 15, 2026

Study information

• Verified date: December 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 15, 2026
• Est. primary completion date: December 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis
We Will take Both blood and tissue samples used to study them. 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. Small tissue samples will be taken from the tissue which is surgically excised as a part of treatment. 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
We Will take Both blood and tissue samples used to study them. 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. Small tissue samples will be taken from the tissue which is surgically excised as a part of treatment. It will include tissue from inner lining of uterus (endometrium) in all participants and from excised endometriosis tissue in patients with endometriosis.

Locations

Country	Name	City	State
India	Shraddha Ramchandani	Hyderabad	Telanagana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Secondary	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..	3 years