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CTRI Number  CTRI/2025/02/081106 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 14/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Experimental 
Study Design  Other 
Public Title of Study   RNA based biomarkers in breast cancer patients 
Scientific Title of Study   To investigate the clinical diagnostic potential of dysregulated microRNAs as early biomarkers in breast cancer patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PRAMOD KUMAR AVTI 
Designation  ADDITIONAL PROFESSOR 
Affiliation  POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH 
Address  DEPARTMENT OF BIOPHYSICS RESEARCH B BLOCK POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH SECTOR 12 CHANDIGARH INDIA Chandigarh CHANDIGARH 160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  9876955337  
Fax    
Email  pramod.avti@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PRAMOD KUMAR AVTI 
Designation  ADDITIONAL PROFESSOR 
Affiliation  POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH 
Address  DEPARTMENT OF BIOPHYSICS RESEARCH B BLOCK POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH SECTOR 12 CHANDIGARH INDIA Chandigarh CHANDIGARH 160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  9876955337  
Fax    
Email  pramod.avti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR DIVYA DAHIYA 
Designation  PROFESSOR 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  DEPARTMENT OF GENERAL SURGERY POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH SECTOR 12 CHANDIGARH INDIA

Chandigarh
CHANDIGARH
160012
India 
Phone  9501583520  
Fax    
Email  dahiyadivya30@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Chandigarh, India 160012 
 
Primary Sponsor  
Name  PRAMOD KUMAR AVTI 
Address  DEPARTMENT OF BIOPHYSICS RESEARCH B BLOCK POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH SECTOR 12 CHANDIGARH INDIA 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR PRAMOD KUMAR AVTI  POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH  OT Surgicals, 5th Floor, Department of General Surgery Nehru Hospital, Postgraduate Institute of Medical Education and Research Chandigarh Chandigarh CHANDIGARH
Chandigarh
CHANDIGARH 
9876955337

pramod.avti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. Female breast cancer patients.
2. Breast cancer patient age between 20-80 years.
3. Patient diagnosed through mammographic
techniques.
4. All stages of diseases.
5. Surgery or mastectomy patients will be included.
6. With or without treatment patients will be included in this study.  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post surgical breast tumor tissue/blood will be collected for miRNAs expression, tumor suppressor genes, DNA repair genes and breast cancer receptor marker expression.  The samples will be processed and analyzed at 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   28/02/2025 
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="2"
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  
The dysregulation of epidermal growth factor receptors and hormonal receptors in breast cancer can be attributed to various factors, including the influence 
of non-coding RNAs, particularly microRNAs. 
These small RNA molecules play a pivotal role in post-
transcriptional gene regulation and have been implicated 
as key players in breast cancer pathogenesis. In breast cancer, aberrant expression of miRNAs has been 
observed, with many miRNAs found to be upregulated. These dysregulated miRNAs exert their influence by 
modulating DNA repair activity and tumor suppressor 
functions, thereby promoting cancer initiation and 
progression and contributes to the molecular complexity 
of breast cancer.

This study aims to delve into the intricate role of miRNAs 
in the progression of breast cancer, elucidating their 
influence on molecular markers, tumor suppressor genes, and DNA repair activity within breast cancer patient 
samples. By analyzing a panel of miRNAs in these 
patients, we seek to uncover potential biomarkers crucial 
for diagnosing breast cancer early and distinguishing 
between different subsets of the disease within a single 
comprehensive study.
 
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