Endometriosis Clinical Trial
— ENDMETOfficial title:
MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis
Verified date | December 2023 |
Source | Asian Institute of Gastroenterology, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | December 15, 2026 |
Est. primary completion date | December 15, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | Shraddha Ramchandani | Hyderabad | Telanagana |
Lead Sponsor | Collaborator |
---|---|
Asian Institute of Gastroenterology, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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.. | 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01931670 -
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
|
Phase 3 | |
Recruiting |
NCT05648669 -
A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain
|
Phase 3 | |
Completed |
NCT04081532 -
The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain
|
N/A | |
Recruiting |
NCT06101303 -
Endometriosis Pain
|
||
Completed |
NCT04665414 -
Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
|
||
Completed |
NCT03690765 -
Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
|
||
Recruiting |
NCT05153512 -
ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
|
||
Active, not recruiting |
NCT04171297 -
Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
|
||
Recruiting |
NCT04172272 -
The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures
|
N/A | |
Completed |
NCT04565470 -
Strategies of Self-management of Endometriosis Symptoms
|
||
Completed |
NCT03613298 -
Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.
|
N/A | |
Withdrawn |
NCT05568940 -
Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
|
||
Not yet recruiting |
NCT03464799 -
Does Immunotherapy Have a Role in the Management of Endometriosis?
|
||
Active, not recruiting |
NCT03002870 -
Characteristics of Patient Population With Endometriosis
|
N/A | |
Withdrawn |
NCT03272360 -
Endometriosis Biomarker Discovery Study
|
N/A | |
Completed |
NCT02973854 -
Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
|
||
Recruiting |
NCT02481739 -
Laparoscopic Surgical Management of Endometriosis on Fertility
|
N/A | |
Active, not recruiting |
NCT02754648 -
Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve
|
N/A | |
Completed |
NCT06106932 -
GnRH-a on Angiogenesis of Endometriosis
|
N/A | |
Completed |
NCT02387931 -
Supplementation in Adolescent Girls With Endometriosis
|
Phase 4 |