| CTRI Number |
CTRI/2024/03/064191 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Abnormal Drug Reaction Surveillance in Patients Receiving Chemotherapy at a State-Level Cancer Institute |
|
Scientific Title of Study
|
Adverse Drug Reaction Monitoring In Patients Undergoing Chemotherapy At A State-Level Cancer Institute |
| 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. Dixit Goyal |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department Of Pharmacology, Government Medical College, Circular Road, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9620000230 |
| Fax |
|
| Email |
dixitgoyal27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Navyug Raj Singh |
| Designation |
Professor |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, AMRITSAR |
| Address |
Department Of Pharmacology, Government Medical College, Circular Road, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9878634358 |
| Fax |
|
| Email |
navyug69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Dixit Goyal |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department Of Pharmacology, Government Medical College, Circular Road, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9620000230 |
| Fax |
|
| Email |
dixitgoyal27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, Amritsar |
|
|
Primary Sponsor
|
| Name |
Not Available |
| Address |
Not available |
| Type of Sponsor |
Other [NOT AVAILABLE] |
|
|
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 Dixit Goyal |
Government Medical College, Amritsar |
Department Of Pharmacology and Department Of Radiotherapy
Amritsar
PUNJAB |
9620000230
dixitgoyal27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt. Medical College, Amritsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, (2) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients of all age groups receiving cancer chemotherapy and developing at least one ADR.
Patients willing to join the study after giving a written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients receiving concurrent radiotherapy along with chemotherapy.
Patient not willing to give consent for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To detect and assess the adverse drug reactions in patients undergoing cancer chemotherapy using WHO-UMC scale for causality. |
One time enquiry |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the severity of ADRs using the Modified Hartwig and Siegel Scale |
One time enquiry |
| To assess the preventability of ADRs using Modified Schumock and Thornton scale |
One time Enquiry |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/03/2024 |
| 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 Applicable |
| 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
|
This study title is ADVERSE DRUG REACTION MONITORING IN PATIENTS UNDERGOING CHEMOTHERAPY AT A STATE LEVEL CANCER INSTITUTE This study is designed to detect and evaluate the adverse drug reactions manifesting in patients receiving chemotherapy. It will be an intensive, focused approach to adverse drug reactin reporting. The study protocol has already been approved by Institutional Scientific and Ethics Committee, Government Medical College, Amritsar. The study recruitment will start on 24/03/2024. |