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CTRI Number  CTRI/2021/04/033068 [Registered on: 23/04/2021] Trial Registered Prospectively
Last Modified On: 17/05/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Exploratory observational study 
Study Design  Other 
Public Title of Study   Observational study to see how long the SARS CoV-2 virus remains alive in the nose and throat of cancer patients on chemotherapy 
Scientific Title of Study   A Prospective observational study to establish the duration of persistence of replication-competent SARS-CoV-2 in oncology patients with COVID-19 on chemotherapy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chetan Dhamne 
Designation  Associate Professor, Pediatric Medical Oncology 
Affiliation  Tata Memorial Hospital 
Address  R. no. 1111, 11th floor, Homi Bhabha Block, Department of Medical Oncology-Pediatrics, Tata Memorial Hospital. Dr. Ernest Borges Road. Parel. Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  chetandhamne@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chetan Dhamne 
Designation  Associate Professor, Pediatric Medical Oncology 
Affiliation  Tata Memorial Hospital 
Address  R. no. 1111, 11th floor, Homi Bhabha Block, Department of Medical Oncology-Pediatrics, Tata Memorial Hospital. Dr. Ernest Borges Road. Parel. Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  chetandhamne@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chetan Dhamne 
Designation  Associate Professor, Pediatric Medical Oncology 
Affiliation  Tata Memorial Hospital 
Address  R. no. 1111, 11th floor, Homi Bhabha Block, Department of Medical Oncology-Pediatrics, Tata Memorial Hospital. Dr. Ernest Borges Road. Parel. Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  chetandhamne@gmail.com  
 
Source of Monetary or Material Support  
Indian Council for Medical Research (ICMR)-National Institute of Virology (NIV), Sus Road, Pashan, Pune 411021  
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Department of Pediatric Medical Oncology, Tata Memorial Hospital, Dr. Earnest Borges Road. Parel 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pragya Yadav  Indian Council for Medical Research (ICMR)- National Institute of Virology (NIV)  Sus Road, Pashan, Pune. 411021. Maharashtra. India
Pune
MAHARASHTRA 
02026006390

hellopragya22@gmail.com 
Dr Chetan Dhamne  Tata Memorial Hospital  R. no. 1111, 11th floor, Homi Bhabha Block, Department of Medical Oncology-Pediatrics, Tata Memorial Hospital. Dr. Ernest Borges Road. Parel. Mumbai
Mumbai
MAHARASHTRA 
9136660746

chetandhamne@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ICMR-National Institute of Virology Institutional Ethics Committee, R. no. 244, Main Building, MCC Campus, 130/1, Sus Road, Pashan, Pune. 411021. Maharashtra. India  Approved 
Institutional Ethics Committee-II, IRB, Tata Memorial Hospital, Third Floor, Main Building, Dr. Earnest Borges Road. Parel. Mumbai. Pin-400012  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  
Type  Name  Details 
Intervention  Not applicable  Not applicable 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Oncology patients admitted with RT-PCR confirmed COVID-19 illness
2. Age 1 to 80 years
3. Patients willing to consent for additional blood and nasopharyngeal swabs.
 
 
ExclusionCriteria 
Details  1. ICU patients unable to give nasopharyngeal swab or blood sample for study proposes
2. Patients with other inter-current bacterial viral respiratory infections.
3. Patients in palliative therapy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Determine the duration of persistence of replication-competent/infectious virus in oncology patients.  At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment 
 
Secondary Outcome  
Outcome  TimePoints 
1. To establish correlation between RT-PCR (Ct value) and persistence of replication competent SARS-CoV-2  At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment 
2. To identify cancer specific and chemotherapy regimen related risk factors for persistence of replication-competent virus  At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment 
To identify biomarkers (blood parameters like lymphocyte count neutrophil to lymphocyte ratio, inflammatory markers, viral serology) to predict clearance of replication-competent virus in oncology patients on chemotherapy  At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment 
To identify presence of replication-competent virus in oncology patients who demonstrate a positive RT-PCR after two consecutive negative results(Re-infection)  At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment 
To evaluate whether specific cancer diagnoses or regimens of chemotherapy influence the occurrence of mutation in immune dominant regions in SARS-CoV-2 isolates from oncology patients  At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment and during the chemotherapy as per the standards 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/05/2021 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

From the observations coming from the previous studies, it has been seen that the samples from patients who recovered from an initial COVID-19 illness and later developed new symptoms and retested positive by RT-PCR (Reverse transcription polymerase chain reaction) were not capable of detecting the virus. Some previous studies have shown that the SARS-Cov-2 virus can replicate inside the body and is released into the environment from the people having low immune system at that point, making these individuals contagious. However, when infected with SARS-Cov-2 virus, the chances of person recovered from the infection, capable of spreading the virus through upper respiratory tract after the beginning of the initial symptoms of the disease, are very low.

Currently, there is only one published study which provides the elements of the persistence of SARS-CoV-2 in individuals who have low ability to fight against infections. The data from other studies of Tata Memorial Hospital show that the patients on active chemotherapy might be at increased risk of worsening their basic cancer treatment due to the positive nasopharyngeal (NP) swab which delays the administration of chemotherapy. In some previous studies, positive nasopharyngeal swabs were shown to detect virus but failed to detect replication and growth capacity of the virus.

Therefore, it becomes important to collect data of such patients to ensure the clearance of replication capable virus in association with certain surrogate markers of viral resolution that can be identified understand the severity of the illness for planning the chemotherapy accordingly. The study aims to observe 50 oncology patients of age 1 to 80 years over a period of 6 months from the point of their first testing positive for SARS-Cov-2 virus, till they are tested for two consecutive tests. This will help the doctor to optimize the course of chemotherapy for cancer patients affected by COVID-19.  
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