| CTRI Number |
CTRI/2024/09/073887 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the necessity of Extra Granulocyte Colony Stimulating Factor (GCSF) in patients already Getting Peg GCSF after chemotherapy. |
|
Scientific Title of Study
|
Assessing the Need for Rescue Granulocyte Colony Stimulating Factor (GCSF) in patients receiving primary prophylaxis with Peg GCSF post 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 |
Asif Rahman K A |
| Designation |
Senior Resident |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Medical Oncology
Amala Institute of Medical Sciences, 680555
Thrissur
Thrissur
KERALA
680555
India |
| Phone |
8848669835 |
| Fax |
|
| Email |
asifrahmanchndl2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin Oommen Philips |
| Designation |
Associate Professor |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Associate Professor
Department Of Medical Oncology
Amala Institute of Medical Sciences
Thrissur, Kerala
Thrissur
KERALA
680555
India |
| Phone |
9003635373 |
| Fax |
|
| Email |
drashphilsmog@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asif Rahman K A |
| Designation |
Senior Resident |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Medical Oncology
Amala Institute of Medical sciences
Thrissur, Kerala
Thrissur
KERALA
680555
India |
| Phone |
8848669835 |
| Fax |
|
| Email |
asifrahmanchndl2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences
Thrissur, Kerala
Pin 680555 |
|
|
Primary Sponsor
|
| Name |
Amala Institute of Medical Sciences |
| Address |
Amala Institute of Medical Sciences
Amala Nagar, Thrissur, 680555 |
| 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 Asif Rahman K A |
Amala Institute of Medical sciences |
Department of Medical Oncology
Thrissur
KERALA |
8848669835
asifrahmanchndl2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Amala Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients more than 18 years of age
2. Patients with a histopathological proven diagnosis of cancer for whom first-line chemotherapy is being planned
3. High-risk or Intermediate-risk patients with more than or equal to 1 high-risk feature, requiring PEGylated G-CSF as a part of their chemotherapeutic regime.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are on treatment and have previously received chemotherapy or radiation in the past or present.
2. Leukemias (Acute lymphoid leukaemia, acute myeloid leukaemia, and chronic lymphoid leukaemia) will be excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Febrile Neutropenia |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PEG GCSF toxicity |
12 weeks |
| Outcome at first response assessment |
6 months |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
16/09/2024 |
| 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) |
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
|
The phenomenon of primary PEG G-CSF failure and the subsequent utilization of rescue G-CSF represent areas of inquiry that have received limited exploration, despite being encountered frequently by physicians. Our study aims to elucidate the practical application of rescue G-CSF following primary Peg G-CSF failure, as well as to ascertain the incidence of febrile neutropenia in our clinical setting and document the complications associated with the use of rescue G-CSF. |