| CTRI Number |
CTRI/2024/04/066395 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the Role of Fibroblast specific protein-1 in Endometriosis associated Fibrosis Treatment |
|
Scientific Title of Study
|
Understanding the role of fibroblast specific protein1 S100A4 in profibrotic and inflammatory pathways as a possible therapeutic target in managing endometriosis associated fibrosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Dutta |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Reproductive Science
Kasturba Medical College, Manipal
Manipal Academy of Higher Education, Manipal- 576 104, Karnataka, India
Division of reproductive Biology
Udupi
KARNATAKA
576104
India |
| Phone |
08474821844 |
| Fax |
|
| Email |
rahul.dutta@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Dutta |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Reproductive Science
Kasturba Medical College, Manipal
Manipal Academy of Higher Education, Manipal- 576 104, Karnataka, India
Division of reproductive Biology
Udupi
KARNATAKA
576104
India |
| Phone |
08474821844 |
| Fax |
|
| Email |
rahul.dutta@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Dutta |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Reproductive Science
Kasturba Medical College, Manipal
Manipal Academy of Higher Education, Manipal- 576 104, Karnataka, India
Division of reproductive Biology
Udupi
KARNATAKA
576104
India |
| Phone |
08474821844 |
| Fax |
|
| Email |
rahul.dutta@manipal.edu |
|
|
Source of Monetary or Material Support
|
| ICMR Small and Medium Grant, Indian Council of Medical Research
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Indian Council of Medical Research
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Dutta |
Department of Obstetrics & Gynaecology, Kasturba Medical College Manipal |
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8474821844
rahul.dutta@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N711||Chronic inflammatory disease of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
• The study will include women aged 18–40 years with who reported to the health centers due to complaints associated with endometriosis.
• Females with ultrasound, histologic, and surgical confirmation of endometriosis (by laparoscopy or laparotomy) accordance with the guidelines of the American Society for Reproductive Medicine within the last 2 years.
|
|
| ExclusionCriteria |
| Details |
• Patients suffering from any other chronic pain or cancer
• patients with psychological disorders
• patients who had undergone surgery on the abdomen other than for endometriosis
• post-menopausal woman
• Subjects with medical conditions in which a blood draw would be contraindicated (e.g., severe anemia)
• use of antibiotics or probiotic/prebiotic supplements within 60 d of enrollment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pearson correlation will be used to quantify the degree to which S100A4 abundance in peritoneal fluid and pain score/ quality of life scores are related. Similarly, the correlation between S100A4 level and disease status as per ASMR will also be calculated. |
12 months, 24 months, 36 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Concentration of IL1, IL2, IL8 in peritoneal fluid |
2026, at the end of the project |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Conventional
therapy-based interventions against endometriosis faces several implementation
barriers. As a result, large proportion of woman suffering from endometriosis
fail to access appropriate care. To improve the care, there is a
critical need to identify novel interventions effective in treating
endometriosis. The findings of the proposed study will help to advance our
knowledge about RAGE antagonist peptide
based therapeutic intervention for managing fibrosis associated with
endometriosis. If intervention is found to have a positive effect, it has the
potential to make a major contribution for women with endometriosis. We are
further correlating S100A4 level in peritoneal fluid and blood to the degree of
severity of the endometriosis. If a statistical correlation is established, we
can further develop this as a biomarker for the severity of the disease and
recovery from the disease, which will be an invaluable tool to monitor women’s health in a non-invasive way |