Deep Learning Radiomics Model for Predicting Post-cystectomy Outcome in Muscle Invasive Bladder Cancer

Sponsor

First Affiliated Hospital of Chongqing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06092450

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

49.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Muscle invasive bladder cancer (MIBC) has a poor prognosis even after radical cystectomy. Postoperative survival stratification based on radiomics and deep learning may be useful for treatment decisions to improve prognosis. This study was aimed to develop and validate a deep learning radiomics model based on preoperative enhanced CT to predict postoperative survival in MIBC.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Other: develop and validate a deep learning radiomics model based on preoperative enhanced CT image

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Deep Learning Radiomics Model for Predicting Post-cystectomy Outcome From Preoperative CT in Muscle Invasive Bladder Cancer

Actual Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
MIBC patients with pathologically confirmed MIBC after radical cystectomy	Other: develop and validate a deep learning radiomics model based on preoperative enhanced CT image develop and validate a deep learning radiomics model based on preoperative enhanced CT to predict postoperative survival in MIBC

Arm

Intervention/Treatment

MIBC

patients with pathologically confirmed MIBC after radical cystectomy

Other: develop and validate a deep learning radiomics model based on preoperative enhanced CT image

develop and validate a deep learning radiomics model based on preoperative enhanced CT to predict postoperative survival in MIBC

Outcome Measures

Primary Outcome Measures

Overall survival（OS） [up to 10 years]
the time from the date of surgery to death from any cause or the date of last contact (censored observation) at the date of data cut-off.
Recurrence free survival（RFS) [up to 10 years]
the time from the date of surgery to the date of first documented disease recurrence. Patients without recurrence at the time of analysis will be censored.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with pathologically confirmed MIBC after radical cystectomy;
contrast-CT scan less than two weeks before surgery;
complete CT image data and clinical data.

Exclusion Criteria:

patients who received neoadjuvant therapy;
non-urothelial carcinoma;
poor quality of CT images;
incomplete clinical and follow-up data.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology, The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400016

Sponsors and Collaborators

First Affiliated Hospital of Chongqing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mingzhao Xiao, Professor, First Affiliated Hospital of Chongqing Medical University

ClinicalTrials.gov Identifier:

NCT06092450

Other Study ID Numbers:

AI-BLCA
2022-K508

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mingzhao Xiao, Professor, First Affiliated Hospital of Chongqing Medical University

Tomography, X-ray computed

Muscle-invasive bladder cancer

Radiomics

Deep Learning

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Study Results

No Results Posted as of Oct 23, 2023