| CTRI Number |
CTRI/2024/12/078333 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Studying Saliva to Detect PCOS: Exploring the Role of microRNA-21 for Early Diagnosis |
|
Scientific Title of Study
|
Evaluation of Salivary microRNA-21 in Polycystic Ovarian Syndrome (PCOS) Patients using RT-PCR – A Baseline Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M ABIRAMI |
| Designation |
Postgraduate student |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology,Karpaga Vinayaga Institute of Dental Sciences,Chinnakolambakkam,
Chengalpet,Tamil Nadu-603308.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7904065950 |
| Fax |
|
| Email |
abi231998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R R Mahendra Raj |
| Designation |
Professor & Head of the Department |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology, Karpaga Vinayaga Institute of Dental Sciences, Chinnakolambakkam,Chengalpet,Tamil Nadu-603308.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7904065950 |
| Fax |
|
| Email |
drmahendraraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
M ABIRAMI |
| Designation |
Postgraduate student |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Department of Oral Medicine & Radiology,Karpaga Vinayaga Institute of Dental Sciences,Chinnakolambakkam,Chengalpet,Tamil Nadu-603308.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7904065950 |
| Fax |
|
| Email |
abi231998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral Medicine & Radiology,
Karpaga Vinayaga Institute of Dental Sciences,
Chinnakolamabakkam,GST road,
Chengelpet,
Tamil Nadu,
India.
603308 |
|
|
Primary Sponsor
|
| Name |
Central Research laboratory |
| Address |
Karpaga Vinayaga Institute of Medical Sciences,Chengelpet,Tamil Nadu,India.
603308 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ms Darshini |
Institute of Basic Medical Sciences |
Department of Genetics,
Institute of Basic Medical Sciences,University of Madras,Taramani Campus,Chennai-600113.
Chennai
TAMIL NADU |
9566226766
abirami.mum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karpaga Vinayaga Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Salivary Sample Collection and Analysis for microRNA-21 Quantification |
Sample Collection:
Unstimulated whole saliva will be collected from participants.
The saliva will be preserved with RNAlater (QIAGEN, Inc.) for whole saliva or SUPERase.In (Ambion, Inc.) for the supernatant phase to ensure RNA integrity.
RNA Extraction and Processing:
Saliva samples will be processed for RNA extraction using the mirVana miRNA Isolation kit.
Extracted RNA will be converted to complementary DNA (cDNA) using the TaqMan MicroRNA reverse transcription kit with miRNA-specific primers.
Quantification of microRNA-21:
Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) will be performed to measure the expression levels of microRNA-21 in the saliva samples.
Diagnostic Comparison:
The expression levels of microRNA-21 in PCOS patients will be compared with those in healthy controls to assess its diagnostic potential.
Duration of intervention - 2 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Volunteering participants
Age criteria: 18 to 30 years
Patients who are diagnosed with PCOS
Gender: Females
|
|
| ExclusionCriteria |
| Details |
Patients under treatment for PCOS
Controls included any known medical conditions or disease
Pregnancy and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the differential expression of salivary microRNA-21 in Polycystic Ovarian Syndrome (PCOS) patients compared to healthy controls, establishing its potential as a non-invasive diagnostic biomarker. |
Baseline (1–6 Months):Collect unstimulated saliva samples from PCOS patients and controls.
7th Month:
Week 1: Extract microRNA.
Week 2: Quantify and qualify microRNA.
Week 3: Prepare microRNA-21 and RNU6 primers.
Week 4: Convert RNA to cDNA.
8th Month:
Week 1: Perform RT-qPCR for microRNA-21 expression.
Weeks 2 and 3: Conduct statistical and ROC curve analysis to evaluate diagnostic potential. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
31/12/2024 |
| 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="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 - NO
|
|
Brief Summary
|
Title: Evaluation of Salivary microRNA-21 in Polycystic Ovarian Syndrome (PCOS) Patients Using RT-qPCR – A Baseline Study Objective:
This study aims to explore the potential of salivary microRNA-21 as a non-invasive biomarker for diagnosing PCOS. By evaluating and comparing its expression levels in PCOS patients and healthy individuals, the study seeks to establish the diagnostic utility of salivary microRNA-21. Methodology: - Design: Cross-sectional study over 2 years.
- Population: 100 participants (50 PCOS patients and 50 healthy controls).
- Sampling: Random selection following strict inclusion and exclusion criteria.
- Sample Collection: Unstimulated saliva samples preserved with specialized reagents for RNA extraction.
- Analysis: RNA extraction, reverse transcription to cDNA, and quantification using RT-qPCR. Statistical methods will include t-tests, ANOVA, and ROC curve analysis.
Expected Implications:
The research could pave the way for using saliva as a patient-friendly and cost-effective diagnostic sample for PCOS, enabling early intervention and reducing associated morbidities. Additionally, it might advance the field of saliva-based diagnostics for other diseases. This innovative approach can serve as a benchmark for non-invasive diagnostic techniques in reproductive and systemic health. |