| CTRI Number |
CTRI/2024/09/074525 [Registered on: 30/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Side effects in cancer patients using medicines for their treatment. |
|
Scientific Title of Study
|
Adverse Drug Reaction monitoring in oncology patients receiving chemotherapy for generating safety indicators |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sriya Lingamagunta |
| Designation |
Pharm D student |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9347692486 |
| Fax |
|
| Email |
sriya.lingamagunta@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudeva Bhat K |
| Designation |
Professor and Head, Department of Pediatric Hematology and Oncology, Kasturba Hospital, Manipal. |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education |
| Address |
Room no. 01, Department of Pediatric Hematology and Oncology, Kasturba Hospital, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9619114703 |
| Fax |
|
| Email |
vasudev.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh V |
| Designation |
Associate Professor, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences |
| Affiliation |
Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education |
| Address |
Room no. 07, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9538417313 |
| Fax |
|
| Email |
rajesh.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
MANIPAL ACADEMY OF HIGHER EDUCATION, MADHAV NAGAR, MANIPAL-576104, KARNATAKA, INDIA |
| Type of Sponsor |
Other [PRIVATE UNIVERSITY] |
|
|
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 Vasudeva Bhat |
Medical oncology ward and Pediatric oncology and hematology ward |
Room no. 01, Department of medical oncology, Shirdi Sai baba block, Kasturba Hospital, Manipal AND Room no. 01, Department of pediatric oncology and hematology, Women and child block, Kasturba hospital, Manipal.
Udupi
KARNATAKA |
9619114703
vasudev.bhat@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 - 2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients under chemotherapeutic regimen, developed ADR and willing to
participate. |
|
| ExclusionCriteria |
| Details |
Outpatients Not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The incidence rate for ADRs in the study population will be identified.
2. The causality of ADRs will be identified. |
Just 1 time point after the participant has developed adverse drug reaction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A list of indicators for ADRs will be identified |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/10/2024 |
| 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="0"
Months="6"
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
|
A prospective, cross-sectional study will be conducted at the Department of Oncology (Medical
Oncology, Surgical Oncology, Palliative Medicine, Pediatric and Radiotherapy) of Kasturba Hospital,
Manipal. Patients will be identified in the oncology wards based on inclusion criteria. Throughout the
duration of the study, consent will be obtained from the patients and confidentiality will be maintained.
Patient case files will be assessed for identification of ADRs, and data will be collected according to the
data collection form. Causality assessment of the ADRs will be done and their outcome will be studied.
Indicators will be identified based on the ADRs found. Data analysis and interpretation will be done using
Jamovi software. |