| CTRI Number |
CTRI/2025/01/078920 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Investigating the Influence of Contributing Factors on the Development of Uterine Fibroids in Women |
|
Scientific Title of Study
|
Integrative Multiomics Study Of Uterine Fibroid Pathogenesis among Indian Women at Tertiary Health Care Centre (Ahmedabad) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Mohan Nair |
| Designation |
Junior Research Fellow |
| Affiliation |
Gujarat Technological University School of Pharmacy |
| Address |
Gujarat Technological University School of Pharmacy, Gandhinagar
Campus Nr. Government Polytechnic K6 Circle, E4 Electronic Estate
G.I.D.C, Sector 26, Gandhinagar
Gandhinagar
GUJARAT
382028
India |
| Phone |
7303697998 |
| Fax |
|
| Email |
jrf_sneha@gtu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashyap Thummar |
| Designation |
Assistant Professor |
| Affiliation |
Gujarat Technological University School of Pharmacy |
| Address |
Gujarat Technological University School of Pharmacy, Gandhinagar
Campus Nr. Government Polytechnic K6 Circle, E4 Electronic Estate
G.I.D.C, Sector 26, Gandhinagar
Gandhinagar
GUJARAT
382028
India |
| Phone |
9427979959 |
| Fax |
|
| Email |
ap_kashyap@gtu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Mohan Nair |
| Designation |
Junior Research Fellow |
| Affiliation |
Gujarat Technological University School of Pharmacy |
| Address |
Gujarat Technological University School of Pharmacy, Gandhinagar
Campus Nr. Government Polytechnic K6 Circle, E4 Electronic Estate
G.I.D.C, Sector 26, Gandhinagar
Gandhinagar
GUJARAT
382028
India |
| Phone |
7303697998 |
| Fax |
|
| Email |
jrf_sneha@gtu.edu.in |
|
|
Source of Monetary or Material Support
|
| GSBTM (Gujarat State Biotechnology Mission)
Block 11, 9th floor, GH Rd, Sector 11, Gandhinagar, Gujarat 382010 |
|
|
Primary Sponsor
|
| Name |
GUJARAT STATE BIOTECHNOLOGY MISSION |
| Address |
Block 11, 9th floor, GH Rd, Sector 11, Gandhinagar, Gujarat 382010 |
| 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 |
| Sneha Mohan Nair PI |
GMERS Medical College and Civil Hospital Ahmedabad |
Obst.Gynaecology Department
Ahmadabad
GUJARAT |
07303697998
jrf_sneha@gtu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic committee, GMERS Medical Collage and Civil Hospital, Sola, Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
The study type is Diagnostic Interventional |
The study type is diagnostic interventional and hence the blood samples collected from cases and controls will be subjected to tests like biochemical parameters and bile acid measurement. The control group will be female not diagnosed with uterine fibroid and the case group will be females diagnosed with uterine fibroid. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Age and BMI-matched premenopausal women of 25-50 years of age from tertiary health care center in Ahmedabad, with different gynecological complaints.
2. All of them will receive an ultrasound scan. Among them, women with at least one fibroid (mean volume of ≥ 2 cm3) will be recruited.
3. We will also recruit women who are willing to/undergoing hysterectomy surgery.
4. The rest of the patients who will have normal ultrasonography scans will be recruited as controls (i.e., non-fibroid patients). |
|
| ExclusionCriteria |
| Details |
1. Women with Polycystic ovary syndrome, Endometriosis, Adenomyosis, pregnancy or pregnancy within the last 6 months.
2. Currently breastfeeding or breastfeeding within the last 6 months; history of acute or chronic neoplasm; history of smoking and alcohol consumption.
3. Hormonal treatment, including oral contraceptives and antibiotics, within the last 1 month. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Defining the relationship between the risk factors (Vitamin D, estrogen, and metabolic syndrome) of uterine fibroids with bile acids.
Insight into the gene expression profiles of uterine smooth muscle cells, and revealing any positive association with bile acid.
Insight into alterations in gut microbiota and its association with bile acid homeostasis in uterine fibroid patients |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Uncovering novel molecular targets or pathways that may help in early detection and
prognosis of uterine fibroids. |
8 Months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/02/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jrf_sneha@gtu.edu.in].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Uterine fibroids are a common condition affecting a staggering 60% of reproductive-age women globally. While these mostly benign growths may not cause any symptoms, 25% of patients may experience debilitating morbidities, including heavy menstrual bleeding, pelvic pressure, urinary symptoms, infertility, and pregnancy complications .Unfortunately, currently available hormone-based therapies provide only temporary relief and frequently trigger undesirable side effects, with hysterectomy often remaining the only solution for lasting relief. This places a considerable economic burden on patients and healthcare systems, making it crucial to uncover novel molecular targets or pathways that may help in early detection and prognosis of uterine fibroids and develop novel therapy. To achieve this, our study aims to investigate the bile acid levels in the blood samples of women as well as the gut microbiota of women with uterine fibroids to those of age and BMI-matched non-fibroid women and then analyze the transcriptome of uterine smooth muscle cells. |