Endometriosis
Conditions
Keywords
lining of uterus, Diarrhea or constipation during a menstrual period., Heavy or irregular periods., Spotting or bleeding between menstrual periods.
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.
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.
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways | 3 years | ROC curve analysis is to estimate the sensitivity and specificity of miRNA expression levels to establish them as biomarkers for endometriosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 3 years | Western Blot and immunohistochemical analysis (IHC) for expression analysis.. |
Countries
India
Outcome results
None listed