| 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
|
|
|
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
|
|
|
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
|
|
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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. |