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

Asian Institute of Gastroenterology, India

Status: Active, not recruiting

Conditions: Endometriosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06168097

Endometriosis-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis

Experimental group

Description:

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.

Treatment:

Procedure: 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis

Procedure: women with intraoperative and / or histopathology findings suggestive of endometriosis

100 women undergoing surgery for gynaecological disorders other than endometriosis or adenomyosis

No Intervention group

Description:

. 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.