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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06168097
Other study ID # Endometriosis-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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