EndometriosisENDMETNCT06168097
The Use of MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis
A study testing 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis and women with intraoperative and / or histopathology findings suggestive of endometriosis in people with Endometriosis, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis and women with intraoperative and / or histopathology findings suggestive of endometriosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 15 Nov 2023to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis
OBJECTIVES :
- 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.
- To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways.
- 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.
- It will include tissue from inner lining of uterus (endometrium) in all participants and from excised endometriosis tissue in patients with endometriosis.
- Conditions
- Endometriosis
- Being tested
- 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis, women with intraoperative and / or histopathology findings suggestive of endometriosis
- Keywords
- lining of uterus, Diarrhea or constipation during a menstrual period., Heavy or irregular periods., Spotting or bleeding between menstrual periods.
- Medical subject headings
- Endometriosis, Diarrhea, Menstruation Disturbances, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosisProcedure or surgery
- We Will take Both blood and tissue samples used to study them.
- 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.
- Small tissue samples will be taken from the tissue which is surgically excised as a part of treatment.
- 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 endometriosisProcedure or surgery
- We Will take Both blood and tissue samples used to study them.
- 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.
- Small tissue samples will be taken from the tissue which is surgically excised as a part of treatment.
- It will include tissue from inner lining of uterus (endometrium) in all participants and from excised endometriosis tissue in patients with endometriosis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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..
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start15 Nov 2023
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- case control study 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis and 100 women undergoing surgery for gynaecological disorders
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shraddha Ramchandani, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168097
- Sponsor's protocol ID
- Endometriosis-01
- Acronym
- ENDMET
- Status last verified
- Dec 2023
- First submitted
- 21 Oct 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis
- ClinicalTrials.gov ID
- NCT06168097
- Acronym / sponsor ID
- ENDMET / Endometriosis-01
- Conditions
- Endometriosis
- Keywords
- lining of uterus, Diarrhea or constipation during a menstrual period., Heavy or irregular periods., Spotting or bleeding between menstrual periods.
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES :
- 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.
- To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways.
- 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.
- It will include tissue from inner lining of uterus (endometrium) in all participants and from excised endometriosis tissue in patients with endometriosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- case control study 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis and 100 women undergoing surgery for gynaecological disorders
| Arm | Type | Receives |
|---|---|---|
| 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis | Experimental | Procedure: 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis, Procedure: women with intraoperative and / or histopathology findings suggestive of endometriosis1. 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 | 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis1. 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 or surgery | 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis |
| women with intraoperative and / or histopathology findings suggestive of endometriosis1. 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 or surgery | 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis |
Primary outcome
2. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways
Time frame: 3 years
ROC curve analysis is to estimate the sensitivity and specificity of miRNA expression levels to establish them as biomarkers for endometriosis.
1 secondary outcome
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)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shraddha Ramchandani principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of endometriosis and women with intraoperative and / or histopathology findings suggestive of endometriosis in people with Endometriosis, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.