Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy

July 15, 2022 updated by: Chang-Ming Huang, Prof., Fujian Medical University

Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy and Postoperative Adjuvant Chemotherapy Benefit in Advanced Gastric Cancer: a Two-center Study

Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking. Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking.

Methods: Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit. Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC), and TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC). 193 patients with AGC from January 2010 to December 2018 in two different China university hospitals were included in this study. The before neoadjuvant chemotherapy imaging scoring system (BNCISS), imaging change scoring system before and after neoadjuvant chemotherapy (ICSS), which were constructed based on computed tomography images before after treatment.

Study Type

Observational

Enrollment (Actual)

193

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Department of Gastric Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospective collection and a retrospective analysis of patients seen from January 2010 to December 2018 at Fujian Medical University Union Hospital (FMUUH) and the First Hospital of Lanzhou University (FHLU) who were diagnosed with gastric adenocarcinoma and underwent radical resection yielded 193 neoadjuvant chemotherapy (NC) patients, including 148 cases from FMUUH (derivation cohort) and 45 cases from the FHLU (validation cohort). Of the 148 patients from FMUUH, 139 had computed tomography (CT) images before NC, 141 had CT images after NC, and 132 had CT images before and after NC. All 45 patients in the FHLU underwent CT before and after NC. Patients with concurrent malignant disease, distant metastases, palliative resection, or gastric stump cancer were excluded.

Description

Inclusion Criteria:

  • Prospective collection and a retrospective analysis of patients seen from January 2010 to December 2018 at Fujian Medical University Union Hospital (FMUUH) and the First Hospital of Lanzhou University (FHLU) who were diagnosed with gastric adenocarcinoma and underwent radical resection

Exclusion Criteria:

  • Patients with concurrent malignant disease, distant metastases, palliative resection, or gastric stump cancer were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
good response to neoadjuvant chemotherapy (GRNC)
Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC)
Other: response to neoadjuvant chemotherapy
Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC), and TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC).
poor response to neoadjuvant chemotherapy (PRNC)
TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC).
Other: response to neoadjuvant chemotherapy
Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC), and TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC for ICSS
Time Frame: 2022-01-01 to 2022-07-31
The predictive performance of imaging change scoring system before and after neoadjuvant chemotherapy (ICSS)
2022-01-01 to 2022-07-31
AUC for BNCISS
Time Frame: 2022-01-01 to 2022-07-31
The predictive performance of before neoadjuvant chemotherapy imaging scoring system (BNCISS)
2022-01-01 to 2022-07-31

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2010-01-01 to 2022-07-31
3 year overall survival
2010-01-01 to 2022-07-31
disease free survival
Time Frame: 2010-01-01 to 2022-07-31
3 year disease free survival
2010-01-01 to 2022-07-31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Investigators

  • Study Director: Hualong Zheng, 291167038@qq.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2022

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

July 10, 2022

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

July 15, 2022

First Posted (Actual)

July 19, 2022

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 15, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMUUH-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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