| CTRI Number |
CTRI/2024/06/069073 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Predictors of risks due to adriamycin-based treatment in breast cancer. |
|
Scientific Title of Study
|
A prognostic risk model for the occurrence of serious adverse events in breast cancer patients on Adriamycin-based chemotherapy. |
| 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 R Siddhanth |
| Designation |
Juniour Resident |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Pharmacology Kasturba Medical College Manipal University Madhav Nagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
917799664565 |
| Fax |
|
| Email |
r.sid97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G. Shivaprakash |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Pharmacology Kasturba Medical College Manipal University Madhav Nagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
919449553742 |
| Fax |
|
| Email |
shiva.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Siddhanth |
| Designation |
Juniour Resident |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Pharmacology Kasturba Medical College Manipal University Madhav Nagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
917799664565 |
| Fax |
|
| Email |
r.sid97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, MAHE, Manipal University Madhav Nagar, Manipal
Karnataka
India
576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College MAHE Manipal |
| Address |
Kasturba Medical College, MAHE, Manipal University Madhav Nagar, Manipal
Karnataka
India
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 R Siddhanth |
Department of Medical Oncology, Shirdi Sai Baba cancer block, 1st floor, Room no 14. |
Kasturba Medical College, Manipal Academy of Higher Education,
Madhav Nagar,
Manipal
576104
Udupi
KARNATAKA |
917799664565
r.sid97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College & Kasturba Hospital Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL, as this is an observational study. |
NIL, as this is an observational study. |
| Comparator Agent |
NIL, as this is an observational study. |
NIL, as this is an observational study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Women above the age of 18 years diagnosed with breast cancer and receiving Adriamycin based therapy. |
|
| ExclusionCriteria |
| Details |
Women suffering from any other malignancies or on any other anti-cancer drugs. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occurrence of serious adverse events (SAE) in breast cancer patients on adriamycin based regimen. |
Risk factor data will be collected & assessed following Adriamycin-based regimen every day for 21 days at cycles 1,2,3,4,5 & 6. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the pattern of serious adverse events in breast cancer patients on adriamycin-based regimen. |
Data on SAEs will be collected as per the predetermined data collection tool following Adriamycin-based regimen every day for 21 days at cycles 1,2,3,4,5 & 6. |
|
|
Target Sample Size
|
Total Sample Size="688"
Sample Size from India="688"
Final Enrollment numbers achieved (Total)= "688"
Final Enrollment numbers achieved (India)="688" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2024 |
| Date of Study Completion (India) |
11/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/03/2026 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
records of breast cancer patients undergoing Adriamycin-based therapy at the
medical oncology dept will be assessed for the occurrence of serious adverse
events (SAEs). The patient’s demographic and baseline data will be recorded by
a pre-formed questionnaire. Predictor risk factors will be analysed for the occurrence of SAEs. All the potential risk factors for causing SAEs will be noted and considered for construction and validation
of nomogram.
|