| CTRI Number |
CTRI/2021/09/036590 [Registered on: 17/09/2021] Trial Registered Prospectively |
| Last Modified On: |
16/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Anti cancer therapy in COVID-19 time |
|
Scientific Title of Study
|
The safety of symptom based administration of chemotherapy in cancer patients during the ongoing COVID-19 pandemic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| COVID 19 Clinical Research Protocol Version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash Kumar |
| Designation |
Assistant Professor |
| Affiliation |
NCI AIIMS |
| Address |
Room No 1, 1st Floor, Academic Block, NCI - AIIMS, Badsa, Jhajjar, Haryana
Jhajjar
HARYANA
124105
India |
| Phone |
9910850134 |
| Fax |
|
| Email |
akashjha08@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akash Kumar |
| Designation |
Assistant Professor |
| Affiliation |
NCI AIIMS |
| Address |
Room No 1, 1st Floor, Academic Block, NCI - AIIMS, Badsa, Jhajjar, Haryana
HARYANA
124105
India |
| Phone |
9910850134 |
| Fax |
|
| Email |
akashjha08@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Akash Kumar |
| Designation |
Assistant Professor |
| Affiliation |
NCI AIIMS |
| Address |
Room No 1, 1st Floor, Academic Block, NCI - AIIMS, Badsa, Jhajjar, Haryana
HARYANA
124105
India |
| Phone |
9910850134 |
| Fax |
|
| Email |
akashjha08@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Cancer Institute, Badsa, Jhajjar, Haryana |
|
|
Primary Sponsor
|
| Name |
NCI AIIMS |
| Address |
NCI - AIIMS, Badsa, Jhajjar, Haryana |
| 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 Akash Kumar |
NCI |
Room No 1, 1st Floor, Academic Block
Jhajjar
HARYANA |
9910850134
akashjha08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional ethics review |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of malignancy (solid, hematologic)
Had received any form of systemic therapy
(chemotherapy, harmonal, targeted,
immunotherapy, metronomic) in between 1st
March 2020 to 28th February 2021
Histopathological diagnosis of cancer |
|
| ExclusionCriteria |
| Details |
Had documented personal or family history of COVID-19 infection prior to systemic therapy administration
Patients who had received anti-cancer systemic therapy at different cancer center before registration during the study period |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the risk of COVID-19 related death among cancer patients during the systemic anti-cancer therapy |
28th february 2021 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the risk of COVID-19 related death among cancer patients who received the systemic anti-cancer therapy during the study period
To determine the factors associated with COVID-19 related death |
1 year |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
29/09/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
COVID-19 pandemic has challenged and changed the delivery of anti-cancer therapy. However there remain uncertainty of the safety of anti-cancer systemic therapy among medical oncologist. The recommendations lack evidence and are mainly consensus statements. We continue to provide anti-cancer therapy for several reasons: most cases being advanced, symptomatic, high disease burden, uncertainty of duration of ongoing COVID-19 pandemic. The idea of this retrospective analysis is to share the chemotherapy experience in the setting of resource limitation. The result may guide about the safety of anti-cancer systemic therapy during COVID-19 pandemic. It may help further in decision making for anti-cancer systemic therapy. |