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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
Intervention / Comparator Agent
|
|
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.
|