| CTRI Number |
CTRI/2024/10/074631 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Risk and side effects of Gefitinib in Lung Cancer patients |
|
Scientific Title of Study
|
Influence of Single Nucleotide Polymorphisms on Disease Susceptibility and Gefitinib-induced Toxicities in Lung 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)
Modification(s)
|
| Name |
Pratheek J |
| Designation |
6th PharmD Student |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE, Manipal |
| Address |
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 |
8310848961 |
| Fax |
|
| Email |
pratheek3651@gmail.com |
|
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 |
Pratheek J |
| Designation |
PharmD student |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE, Manipal |
| Address |
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 |
8310848961 |
| Fax |
|
| Email |
pratheek.j@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Intramural Fund, Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Intramural Fund, MAHE, Manipal |
| Address |
Manipal Academy of Higher Education (MAHE), Manipal |
| 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- 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C343||Malignant neoplasm of lower lobe,bronchus or lung, (2) ICD-10 Condition: C340||Malignant neoplasm of main bronchus, (3) ICD-10 Condition: C342||Malignant neoplasm of middle lobe,bronchus or lung, (4) ICD-10 Condition: C348||Malignant neoplasm of overlappingsites of bronchus and lung, (5) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, (6) ICD-10 Condition: C341||Malignant neoplasm of upper lobe,bronchus or lung, |
|
|
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 |
Both |
| Details |
1. Lung cancer patients (both males and females) with EGFR positive mutation.
2. Patients who are 18 years and above.
3. Patients who are willing to give informed consent.
4. Controls: Individuals (18 years and above) without lung cancer who are willing to
take part in the study. |
|
| ExclusionCriteria |
| Details |
1. HIV positive patients.
2. Patients with seriously ill conditions or clinically unstable patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study aims to provide an overview of the association of NAT2 gene polymorphisms towards
lung cancer susceptibility in a tertiary care hospital. The current study explores the association of CYP2D6 gene polymorphisms with gefitinib-induced toxicities in lung cancer patients. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Current study could help in deriving individualized drug dosing strategies for improving treatment outcomes, reducing ADRs, and therapeutic compliance. This would pave the way for large-scale cancer pharmacogenomic studies to revitalize precision medicine for Indian lung cancer patients |
1 year |
|
|
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)
|
07/10/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 blood samples of controls (without lung cancer) and lung cancer patients and record the associated demographic and clinical details. The lung cancer susceptibility and pharmacogenomic analysis will be conducted using these samples. We intend to look at the single nucleotide polymorphism of CYP2D6 gene which is associated with Gefitinib induced toxicity |