PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 19:18:17 GMT)

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 Trial Public Title of Study COVID-19 and cancer chemotherapy Scientific Title of COVID-19 and cancer chemotherapy- collate data on treatment patterns, short-term outcomes and Study patient experience Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Bhawna Sirohi Trial Coordinator (multi-center study) 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 Max Super Speciality Hospital, Saket (A unit of Devki Devi Foundation) 2, Press Enclave Road, Saket, - 110017 New Delhi DELHI 110017 Phone 9756999976 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Bhawna Sirohi Query) 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 [email protected] Details Contact Details Contact Person (Public Query) 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

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New Delhi DELHI 110017 India Phone 9756999976 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Max Super Speciality Hospital, Saket (A unit of Devki Devi Foundation) Primary Sponsor Primary Sponsor Details 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 Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Ankur Bahl Max Super Speciality Max Super Speciality 9756999976 Hospital, DDF, Saket Hospital, DDF, Saket South [email protected] DELHI m Dr Bhawna Max Super Speciality Max Super Speciality 9756999976 Hospital, Gurugram Hospital, Gurugram Gurgaon bhawna.sirohi13@gmail HARYANA .com Dr Nitesh Rohatgi Max Super Speciality Max Super Speciality 8130233730 Hospital, Hospital, Lajpat Nagar New Delhi nitesh.rohatgi@maxhea DELHI lthcare.com Dr Meenu Walia Max Super Speciality Max Super Specialty, 9818994001 Hospital, PPG Hospital,(A unit of Balaji Medical & Diagnostic meenu.walia@maxhealt Research Centre),108- hcare.com A,Indraprastha Extensio n,Patparganj,Delhi-110 092 East DELHI Dr Waseem Abbas Max Super Speciality Max Super Speciality 9810619717 Hospital, Shalimar Hospital, Shalimar Bagh Bagh waseem.abbas@maxh North East ealthcare.com DELHI Dr Gopal Sharma Max Super Speciality Max Super Speciality 9717978967 Hospital, Vaishali Hospital, Vaishali Ghaziabad gopal.sharma@maxhea lthcare.com Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Submittted/Under No Date Specified No

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Committee, Max Super Review Speciality Hospital, Vaishali Max Hospital, Approved 29/04/2020 No Gurugram Max super speciality Approved 25/04/2020 No hospital Lajpat Nagar, New Delhi Max super speciality Approved 20/04/2020 No hospital (a unit of Balaji Medical and diagnostic reserach center) Max super speciality Approved 13/05/2020 No hospital saket (a Devki devi foundation) Max super speciality Approved 29/04/2020 No hospital shalimar bagh (a unit of Max healthcare institute limited) Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Coronavirus as the cause of diseases classified elsewhere Patients Neoplasms Intervention / Type Name Details Comparator Agent Inclusion Criteria 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 Exclusion Criteria Exclusion Criteria 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 6 months from start of enrollment as a result of the pandemic Secondary Outcome Outcome Timepoints To assess impact on short-term morbidity End of study Assess impact on patient experience (questionnaire based) Target Sample Size Total Sample Size=200 Sample Size from India=200

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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 29/05/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=3 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details As per Publication policy 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.

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