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
-
-
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)
|
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).
|
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
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
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