The Use of MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis
NCT ID: NCT06168097
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2023-11-15
2026-12-15
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
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.
women 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.
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.
No interventions assigned to this group
Interventions
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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.
women 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.
Eligibility Criteria
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Inclusion Criteria
* The probands were chosen randomly from the pool of available endometriosis patients and healthy controls of Indian origin.
Exclusion Criteria
18 Years
45 Years
ALL
Yes
Sponsors
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Asian Institute of Gastroenterology, India
OTHER
Responsible Party
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Principal Investigators
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Shraddha Ramchandani
Role: PRINCIPAL_INVESTIGATOR
Asian Institute of Gastroenterology
Locations
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Shraddha Ramchandani
Hyderabad, Telanagana, India
Countries
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Other Identifiers
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Endometriosis-01
Identifier Type: -
Identifier Source: org_study_id