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

Study Overview
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Brief Summary
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OBJECTIVES : 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. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways. 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
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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.

Official Title
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MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Procedure: 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis
* Procedure: women with intraoperative and / or histopathology findings suggestive of endometriosis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: case control study 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis and 100 women undergoing surgery for gynaecological disorders
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis<br>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<br>* 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.<br>Procedure: women with intraoperative and / or histopathology findings suggestive of endometriosis<br>* 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.<br>|
| No Intervention: 100 women undergoing surgery for gynaecological disorders other than endometriosis or adenomyosis<br>. 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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lining of uterus, Diarrhea or constipation during a menstrual period., Heavy or irregular periods., Spotting or bleeding between menstrual periods.