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

Cervix Cancer Clinical Trial

Official 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05102240
• Other study ID #: TMC IRB 900787
• Secondary ID: CTRI/2021/08/035
• Status: Active, not recruiting
• Start date: February 24, 2022
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Tata Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

1. Low Risk Clinical Target Volume (Low Risk CTV)

2. GTV: Nodal

3. Elective Nodal Pelvic Target Volume

4. Elective Nodal Pelvic and Paraaortic Volume

5. Rectum

6. Bladder

7. Sigmoid

8. Bowel

9. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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:

1. Lack of disease or toxicity outcomes.

2. Lack of images in the hospital database.

Related Conditions & MeSH terms

• Cervix Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
India	Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre	Navi Mumbai	Maharashtra

Sponsors (3)

Lead Sponsor	Collaborator
Tata Memorial Hospital	Bhabha Atomic Research Centre and Indian Institute of Technology, Mumbai., Erasmus Medical Center

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generation of software for automated target delineation for cervix cancer	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.	3 years
Primary	Development and validation of Normal Tissue Complication Plots	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 years
Primary	Identify "high risk patient population" that may benefit from intensification of treatment in future	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 future	3 years