| CTRI Number |
CTRI/2020/05/025217 [Registered on: 17/05/2020] Trial Registered Prospectively |
| Last Modified On: |
21/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
COVID-19 and cancer chemotherapy |
|
Scientific Title of Study
|
COVID-19 and cancer chemotherapy- collate data on treatment patterns, short-term outcomes and patient experience |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhawna Sirohi |
| Designation |
Director, Medical Oncology |
| Affiliation |
Max healthcare |
| Address |
Max Super Speciality Hospital, Saket
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket, New Delhi
Max Super Speciality Hospital, Saket
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket, New Delhi- 110017
New Delhi
DELHI
110017
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawna Sirohi |
| Designation |
Director, Medical Oncology |
| Affiliation |
Max healthcare |
| Address |
Max Super Speciality Hospital, Saket
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket, New Delhi
Max Super Speciality Hospital, Saket
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket, New Delhi- 110017
New Delhi
DELHI
110017
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhawna Sirohi |
| Designation |
Director, Medical Oncology |
| Affiliation |
Max healthcare |
| Address |
Max Super Speciality Hospital, Saket
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket, New Delhi
Max Super Speciality Hospital, Saket
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket, New Delhi- 110017
New Delhi
DELHI
110017
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital, Saket
(A unit of Devki Devi Foundation)
|
|
|
Primary Sponsor
|
| Name |
Dr Bhawna Sirohi |
| Address |
Max Super Speciality Hospital, Saket
(A unit of Devki Devi Foundation)
|
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankur Bahl |
Max Super Speciality Hospital, DDF, Saket |
Max Super Speciality Hospital, DDF, Saket
South
DELHI |
9756999976
drankurbahl@gmail.com |
| Dr Bhawna |
Max Super Speciality Hospital, Gurugram |
Max Super Speciality Hospital, Gurugram
Gurgaon
HARYANA |
9756999976
bhawna.sirohi13@gmail.com |
| Dr Nitesh Rohatgi |
Max Super Speciality Hospital, Lajpat Nagar |
Max Super Speciality Hospital, Lajpat Nagar
New Delhi
DELHI |
8130233730
nitesh.rohatgi@maxhealthcare.com |
| Dr Meenu Walia |
Max Super Speciality Hospital, PPG |
Max Super Specialty, Hospital,(A unit of Balaji Medical & Diagnostic Research Centre),108-A,Indraprastha Extension,Patparganj,Delhi-110092
East
DELHI |
9818994001
meenu.walia@maxhealthcare.com |
| Dr Waseem Abbas |
Max Super Speciality Hospital, Shalimar Bagh |
Max Super Speciality Hospital, Shalimar Bagh
North East
DELHI |
9810619717
waseem.abbas@maxhealthcare.com |
| Dr Gopal Sharma |
Max Super Speciality Hospital, Vaishali |
Max Super Speciality Hospital, Vaishali
Ghaziabad
UTTAR PRADESH |
9717978967
gopal.sharma@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Max Super Speciality Hospital, Vaishali |
Submittted/Under Review |
| Max Hospital, Gurugram |
Approved |
| Max super speciality hospital Lajpat Nagar, New Delhi |
Approved |
| Max super speciality hospital Patparganj (a unit of Balaji Medical and diagnostic reserach center) |
Approved |
| Max super speciality hospital saket (a Devki devi foundation) |
Approved |
| Max super speciality hospital shalimar bagh (a unit of Max healthcare institute limited) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.18 Year(s) |
| Age To |
0.99 Year(s) |
| Gender |
Both |
| Details |
All adult (more than 18 years of age) cancer patients currently on active chemotherapy treatment at Max Institute of Cancer Care |
|
| ExclusionCriteria |
| Details |
Patients not able to give consent
Patient less than 18 years age on the day of enrollment |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To describe change in cancer treatment patterns as a result of the pandemic |
6 months from start of enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess impact on short-term morbidity
Assess impact on patient experience (questionnaire based) |
End of study |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
29/05/2020 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
As per Publication policy |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of this research is to prospectively understand what changes in
treatment clinicians have done and how this has impacted patients care. Patients on chemotherapy will also fill in a
questionnaire to understand the impact COVID-19 has had on them. Our study does
not include any changes in treatment strategy as this would be fairly
subjective and would vary from one clinician
to the other on a case to basis as multiple factors would influence their
decision. |