| CTRI Number |
CTRI/2020/10/028571 [Registered on: 22/10/2020] Trial Registered Prospectively |
| Last Modified On: |
22/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Treatment and followup outcomes of gynecological cancer patients treated with radiation therapy during lockdown phase of COVID pandemic |
|
Scientific Title of Study
|
Outcomes of treatment and followup of patients treated with radiation therapy in
gynecological cancer during lockdown phase of COVID pandemic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supriya Chopra |
| Designation |
Professor, Radiation Oncology |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
| Address |
Room no.L-05, Paymaster Shodhika,Sector 22, Utsav Chowk - CISF Road, Owe Camp, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930958309 |
| Fax |
|
| Email |
supriyasastri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriya Chopra |
| Designation |
Professor, Radiation Oncology. |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
| Address |
Room no.L-05, Paymaster Shodhika,Sector 22, Utsav Chowk - CISF Road, Owe Camp, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930958309 |
| Fax |
|
| Email |
supriyasastri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya Chopra |
| Designation |
Professor, Radiation Oncology. |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
| Address |
Room no.L-05, Paymaster Shodhika,Sector 22, Utsav Chowk - CISF Road, Owe Camp, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930958309 |
| Fax |
|
| Email |
supriyasastri@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Supriya Chopra |
Tata Memorial Centre and Advance Centre for Treatment, Research and Education in Cancer |
Room no, 52,Ground floor, Homi Bhabha Block,Tata Memorial Hospital, Dr. Ernest Borges Road, Parel
Mumbai
MAHARASHTRA |
9930958309
supriyasastri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients treated in Gynecology unit of radiation therapy in TMH, referred out, and/or followed up from 01.03.2020 to 31.07.2020
2. All age groups will be included in the study.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Audit of treatment characteristics of patients treated during COVID- 19 lockdown period. |
01.03.2020 to 31.07.2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compliance of patients |
During COVID- 19 lockdown period. |
| Acute complications and outcomes of treatment of patients treated |
3 years |
| To report on common patient symptoms during telephonic follow up consultation |
During COVID- 19 lockdown period. |
| To report on long term cancer specific outcomes of patients treated |
3 years |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
30/10/2020 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational retrospective cohort study. The primary aim of the study is to audit cancer care of Gynaecological patients of all age groups who were treated, referred outside, and/or on follow-up from 01.03.2020 to 31.07.2020 (or extended COVID-19 pandemic lockdown period as deemed necessary by government). The study will recruit a total of 1500 patients.
|