Clinical trial NCT06168097: The Use of MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis
Official title: MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: lining of uterus
Diarrhea or constipation during a menstrual period.
Heavy or irregular periods.
Spotting or bleeding between menstrual periods.
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: case control study 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis and 100 women undergoing surgery for gynaecological disorders
Primary purpose: DIAGNOSTIC

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 2. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways
timeFrame: 3 years
Secondary outcomes:
measure: 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)
timeFrame: 3 years
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Shraddha Ramchandani
state: Telanagana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Shraddha Ramchandani
role: PRINCIPAL_INVESTIGATOR
References: