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

MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis

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

Study Overview

• Status: Active, not recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Procedure: 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis; Procedure: women with intraoperative and / or histopathology findings suggestive of endometriosis

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telanagana
    • Hyderabad, Telanagana, India, 500082
      • Shraddha Ramchandani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Procedure: 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.
No Intervention: 100 women undergoing surgery for gynaecological disorders other than endometriosis or adenomyosis; . 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Shraddha Ramchandani, Asian Institute of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: October 21, 2023
• First Submitted That Met QC Criteria: December 10, 2023
• First Posted (Estimated): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: lining of uterus; Diarrhea or constipation during a menstrual period.; Heavy or irregular periods.; Spotting or bleeding between menstrual periods.
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: Endometriosis-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No