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Active, not recruitingNCT06168097ENDMETUpdated Dec 13, 2023

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

An interventional study of 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis and women with intraoperative and / or histopathology findings suggestive of endometriosis in Endometriosis, sponsored by Asian Institute of Gastroenterology, India. Active, not recruiting at 1 site in India. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-13.

Sponsored by Asian Institute of Gastroenterology, India · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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

Read the 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.

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Conditions studied

  • Endometriosis

Keywords

  • lining of uterus
  • Diarrhea or constipation during a menstrual period.
  • Heavy or irregular periods.
  • Spotting or bleeding between menstrual periods.
03

In context

Endometriosis

925 studies on the registry are indexed under Endometriosis; 264 are open to participants now.

This study's planned enrollment of 200 is above the median of 65 across 539 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Asian Institute of Gastroenterology, India is the lead sponsor of 134 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

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

    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

  • No intervention
    100 women undergoing surgery for gynaecological disorders other than endometriosis or adenomyosis

    . 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

  • Procedure100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis

    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.

  • Procedurewomen with intraoperative and / or histopathology findings suggestive of endometriosis

    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.

06

What researchers measure

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.

    Time frame: 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)

    Western Blot and immunohistochemical analysis (IHC) for expression analysis..

    Time frame: 3 years

07

Study locations

1 site
  • Shraddha Ramchandani
    Hyderabad, Telanagana 500082, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06168097
Responsible party
Sponsor
First posted
Dec 13, 2023
Start date
Nov 15, 2023
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Dec 13, 2023

Study contacts

Shraddha Ramchandani
principal investigator · Asian Institute of Gastroenterology, India

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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