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CTRI Number  CTRI/2021/08/035810 [Registered on: 19/08/2021] Trial Registered Prospectively
Last Modified On: 18/08/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Development of clinically high efficient platforms for individualised treatment of cervix cancer 
Scientific Title of Study   Developing clinical high efficiency platforms for individualised treatment through integration of advanced radiation technology, quantitative imaging and molecular biology and machine learning for treatment of cervix cancer.  
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 Sastri  
Designation  Professor, Radiation Oncology 
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) 
Address  PS 246,2nd Floor,Paymaster Shodhika ,Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) 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 Sastri  
Designation  Professor, Radiation Oncology 
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) 
Address  PS 246,2nd Floor,Paymaster Shodhika ,Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) 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 Sastri  
Designation  Professor, Radiation Oncology 
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) 
Address  PS 246,2nd Floor,Paymaster Shodhika ,Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) 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  
Tata Memorial Centre, Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012  
 
Primary Sponsor  
Name  Science and Engineering Research Board SERB 
Address  5 & 5A, Lower Ground Floor, Vasant Square Mall Sector-B, Pocket-5,Vasant Kunj New Delhi - 110 070 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 Sastri  Advanced Centre for Treatment, Researc and Tata Memorial Hospital, Tata Memorial Centre  Room no.L-06, Paymaster Shodhika, ACTREC, Sector 22, Utsav Chowk - CISF Road, Kharghar, Navi Mumbai, Raigad, Maharashtra 410210 Raigarh MAHARASHTRA
Raigarh
MAHARASHTRA 
9930958309

supriyasastri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , Tata Memorial Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  1. Patients treated within ongoing and completed clinical trials of chemoradiation and brachytherapy for cervix cancer with access to MRI/CT images at the time of diagnosis and brachytherapy.
2. Patients undergoing postoperative or definitive radiotherapy and treated within trials of postoperative or definitive RT.
 
 
ExclusionCriteria 
Details  1. Lack of disease or toxicity outcomes.
2. Lack of images in the hospital database.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a) Generation of software for automated target delineation for cervix cancer.
b) Development and validation of Normal Tissue Complication Plots.
c) Identify “high risk patient population” that may benefit from intensification of treatment in future. 
3 Years 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="1800"
Sample Size from India="1800" 
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)   23/08/2021 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No publications yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Cervical cancer is the second most common cancer in India. Every year, around 80,000-90,000 women bear the burden of cervical cancer. In recent years, the use of advanced external radiation and brachytherapy techniques have improved the condition of the patients and their overall survival rates. This study proposal is an initiative with International collaborators to develop a robust model of efficient treatment delivery. In order to achieve this goal, we are making a move to integrate the knowledge of advanced technology, existing radiation treatment information, quantitative imaging, and available datasets from completed and ongoing clinical studies so that women diagnosed with Cervical cancer can be provided with highly precise treatment in a time-efficient manner. It is a retrospective study that will use existing database to develop automation and prediction tools.

Study Aims

1.      To develop and validate automated platforms for target delineation and planning for cervix cancer in time-efficient manner through

a.       Machine learning-based detection of abnormal cancerous tissues in multimodality medical diagnostic images.

b.      To train machine base systems for automated planning of external radiation and brachytherapy for gynaecological cancers.

2.      To use existing databases and radiation dose maps, imaging texture features and adverse events data for machine learning to develop “normal tissue complication plots “and to identify cervix cancer patient subgroups that may benefit from advanced radiation techniques (like proton treatment)

3.      To use advanced image texture analysis within ongoing institutional and collaborative clinical trials to identify “high-risk patient population” that may benefit from intensification of treatment in the future.


 
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