Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05102240

Development of Clinically High Efficient Platforms for Individualised Treatment of Cervix Cancer

Retrospective study utilizing patient data to develop and validate Machine Learning application. Available imaging data sets of patients who have completed treatment will be used to develop Normal tissue complication probability and Tumour control probability

Hypothesis Integrating existing radiation treatment information, quantitative imaging and patient outcome data from completed and ongoing clinical trials will allow development of knowledge based systems for efficient treatment delivery and allow selection of patients for intensified treatment approaches in cervix cancer.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre

Navi Mumbai, Maharashtra, 410210, India

Location status: Recruiting

Location contact

Dr Supriya Chopra, MD

CONTACT

[email protected]

91-22-27405000 ext. 5491

Supriya Chopra, MD

PRINCIPAL_INVESTIGATOR

About this study

For Aim 1. Automatic delineation of complex tumour targets for cervical cancer for the Gross Tumour Volume (GTV) at baseline and at brachytherapy and High Risk Clinical Target Volume(CTV) at baseline and brachytherapy will be done on MRI.

Following structures will be processed for automation on CT

  • Low Risk Clinical Target Volume (Low Risk CTV)
  • GTV: Nodal
  • Elective Nodal Pelvic Target Volume
  • Elective Nodal Pelvic and Paraaortic Volume
  • Rectum
  • Bladder
  • Sigmoid
  • Bowel
  • Bone Marrow

For Aim 2. The Investigator intend to employ machine learning for developing more robust normal tissue toxicity prediction models. Further advanced techniques like texture analysis of radiation dose maps and follow up tissue density will also be performed to develop predictive models of toxicity. By using our patient datasets, Investigator want to create a library of proton beam plans with the proton planning systems that will be available in department of radiation oncology and using the developed normal tissue complication plots available the information of achievable doses through protons can help in identifying patients who will benefit from proton therapy.

For Aim 3. Within this project Investigator intend to integrate staging, pathology and quantitative imaging texture features for response prediction and identification of "high risk cohort" in cervix cancer. Images and clinical data from patients that have MRI at baseline will be included The texture features can be used to categorise "good" and "poor responders" after chemoradiation. For the same cohort of patients the Investigator also have tissue available including results of additional biomarkers (like AKT,LICAM, PDL1,CD4 and CD8). The Investigator intend to first correlate difference in texture features and see if there is a pattern of different molecular features. In the second step imaging and molecular features could be integrated for developing" risk prediction models". GTV and HRCTV delineated on 150 data sets at baseline and brachytherapy within Aim 1 will be utilised to categorise responders and non-responders and validate another 150 patient data sets.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For Aim 1 and Aim 3:

  • 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 For Aim 2
  • Patients undergoing postoperative or definitive radiotherapy and treated within trials of postoperative or definitive RT.

Exclusion criteria

  • Lack of disease or toxicity outcomes.
  • Lack of images in the hospital database.

Treatment and study plan

Primary outcomes

  1. Generation of software for automated target delineation for cervix cancer

    Time frame: 3 years

    • 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. Development and validation of Normal Tissue Complication Plots

    Time frame: 3 years

    • 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. Identify "high risk patient population" that may benefit from intensification of treatment in future

    Time frame: 3 years

    • 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 future

Study contacts

Contact information is provided by the study sponsor or research team.

Supriya Sastri (nee Chopra), MD

CONTACT

[email protected]

02227405000 ext. 5113

Supriya Sastri (nee Chopra), MD

CONTACT

[email protected]

02227405000 ext. 5113

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Collaborators

  • Bhabha Atomic Research Centre
  • Erasmus Medical Center

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2021
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.