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CTRI Number  CTRI/2025/12/099784 [Registered on: 24/12/2025] Trial Registered Prospectively
Last Modified On: 23/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational study 
Study Design  Other 
Public Title of Study   A study to look at Health and Recovery of Cancer Patients in the Intensive Care Unit 
Scientific Title of Study   Epidemiology and outcomes of Oncology patients admitted in the ICU 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
901232_Version 1.1 dated 06.11.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpushp Bhosale 
Designation  Professor and head, Division of Critical Care Medicine 
Affiliation  ACTREC TMC 
Address  Department of Anesthesia, Critical Care and Pain, 7th floor, RRS Building, ACTREC, Tata Memorial Centre, Kharghar, Navi Mumbai, 410210

Mumbai
MAHARASHTRA
410210
India 
Phone  9619310657  
Fax    
Email  shilbhosale@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shilpushp Bhosale 
Designation  Professor and head, Division of Critical Care Medicine 
Affiliation  ACTREC TMC 
Address  Department of Anesthesia, Critical Care and Pain, 7th floor, RRS Building, ACTREC, Tata Memorial Centre, Kharghar, Navi Mumbai, 410210

Mumbai
MAHARASHTRA
410210
India 
Phone  9619310657  
Fax    
Email  shilbhosale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shilpushp Bhosale 
Designation  Professor and head, Division of Critical Care Medicine 
Affiliation  ACTREC TMC 
Address  Department of Anesthesia, Critical Care and Pain, 7th floor, RRS Building, ACTREC, Tata Memorial Centre, Kharghar, Navi Mumbai, 410210

Mumbai
MAHARASHTRA
410210
India 
Phone  9619310657  
Fax    
Email  shilbhosale@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesia, Critical care and Pain, OT complex, Seventh floor, RRS Building, ACTREC, Navi Mumbai - 410210 India  
 
Primary Sponsor  
Name  Tata Memorial Centre  
Address  Department of Anaesthesia Critical Care and Pain, ACTREC, Navi Mumbai - 410210 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shilpushp Bhosale   Tata Memorial Centre  Department of Anaesthesia Critical Care and Pain, ACTREC, Kharghar, Navi Mumbai - 410210
Mumbai
MAHARASHTRA 
9619310657

shilbhosale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee: III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  98.00 Year(s)
Gender  Both 
Details  All adult patients admitted in the ICU 
 
ExclusionCriteria 
Details  Patients less than 18 yrs of age and Post BMT patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ICU mortality   At ICU discharge 
 
Secondary Outcome  
Outcome  TimePoints 
1. Hospital Mortality
2. Risk factors that predict mortality on multivariate analysis
 
At ICU discharge 
 
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)   05/01/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

With significant development of treatment of cancer patients, survival and prognosis have been continually improving both for solid and haematological malignancies. Since cancer and treatment related complications are common many patients may need admission to the ICU for managing infectious complications, respiratory failure, septic shock etc. Because of this, requirements for ICU services access and use will continue to increase. It is important to identify patients who are at risk of developing these complications and who will benefit from icu care.

Several prognostic factors including the need for vasopressors and invasive mechanical ventilation have been proposed however, their use in clinical practice is limited because of their lack of external validation and limited predictive power. Early admission to the ICU has been shown to improve survival. The ICU mortality rate in cancer patients is variable and can range between 30 percent and 77 percent. This wide range of mortality rates is due to the multiple factors that may affect outcome in these patients, such as malignancy type, cause of admission, presence of metastasis, number of organ failures, and therapies before ICU admission. We planned to study the characteristics of patients admitted to the ICU and risk factors associated with poor outcomes.

 
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