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

NCT06168097 | Active Not Recruiting

• 1 other identifier: Endometriosis-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES :

1. 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. 2.To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways.
3. 3.Evaluation of significant outcome of objective 1 in serum samples to establish them as biomarkers.

Conditions

Endometriosis

Keywords

lining of uterus; Diarrhea or constipation during a menstrual period.; Heavy or irregular periods.; Spotting or bleeding between menstrual periods.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

  3 years

Study Arms (2)

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

EXPERIMENTAL

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.

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

. 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.

Interventions

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

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.

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

women with intraoperative and / or histopathology findings suggestive of endometriosis PROCEDURE

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.

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of non-endometriotic ovarian cysts, adenomyosis, ovarian cancer, fibroids, and stage I and II endometriosis.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Shraddha Ramchandani

Hyderabad, Telanagana, 500082, India

Location

MeSH Terms

Conditions

Endometriosis; Diarrhea; Menstruation Disturbances; Metrorrhagia

Interventions

Laparoscopy; Laparotomy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Uterine Hemorrhage; Uterine Diseases; Hemorrhage

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Shraddha Ramchandani

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: case control study 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis and 100 women undergoing surgery for gynaecological disorders

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: December 13, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)