| 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
|
|
|
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
|
|
|
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 |
|
|
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. |