| CTRI Number |
CTRI/2024/10/075022 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal Prospective Study |
| Study Design |
Other |
|
Public Title of Study
|
Testing for genetic changes in breast cancer |
|
Scientific Title of Study
|
Genetic Screening of Epigenetic Modifiers in Newly Diagnosed 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 |
Dr Mahadev Rao |
| Designation |
Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE, Manipal |
| Address |
Room No 9, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences 4th floor, MCODS via New OPD block, Kasturba Hospital, Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105706060 |
| Fax |
|
| Email |
mahadev.rao@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahadev Rao |
| Designation |
Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE, Manipal |
| Address |
Room No 9, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences 4th floor, MCODS via New OPD block, Kasturba Hospital, Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105706060 |
| Fax |
|
| Email |
mahadev.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveena AN Kumar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Room No 2, Department of Surgical Oncology, Shirdi Sai Baba Block, Kasturba Medical College, Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9969523579 |
| Fax |
|
| Email |
naveenkumar.an@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Centre for Translational Research and Intra Mural Fund
Manipal Academy of Higher Education, Manipal - 576104
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Intramural Fund, MAHE, Manipal |
| Address |
Centre for Translational Research, MCOPS, MAHE, Manipal- 576104 |
| 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 |
| Dr Mahadev Rao |
Kasturba Medical College and Hospital, Manipal |
Room No 9, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences 4th floor, MCODS via New OPD block, Kasturba Hospital Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
KARNATAKA |
8105706060
mahadev.rao@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: C500||Malignant neoplasm of nipple and areola, (2) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (3) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (4) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (5) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, (6) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (7) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Newly diagnosed female breast cancer patients
2. Patients scheduled for Modified Radical Mastectomy (MRM) or Breast Conservative Surgery (BCS).
3. Patients who are willing to give informed consent.
4. Patients above the age of 18 years. |
|
| ExclusionCriteria |
| Details |
1. Vulnerable patients
2. HIV, TB, Hepatitis positive patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Outcome measures used in this research comprise of demographic and clinical data, histopathology and diagnostic tests reports and descriptions of various treatment regimens used.
2) mRNA expressions of UHRF1
3) mRNA expressions of EZH2
4) mRNA expressions of UBL5
|
3 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlating sociodemographic and clinicopathological parameters with the mRNA expressions of UHRF1, EZH2 and UBL5. |
3 Years |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
14/10/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In our study, we intend to collect the normal and cancerous breast tissue samples of newly diagnosed breast cancer patients and record the associated demographic and clinical details.
The mRNA expression of UBL5, EZH2 and UHRF1 will be studied using these
samples. We will also be analyzing the correlation between mRNA expression with clinicopathological characteristics of the patients. |