Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy

Sponsor
Fujian Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05465512
Collaborator
(none)
193
1
6.1
31.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: response to neoadjuvant chemotherapy

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
193 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy and Postoperative Adjuvant Chemotherapy Benefit in Advanced Gastric Cancer: a Two-center Study
Actual Study Start Date :
Jan 4, 2022
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jul 10, 2022

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. AUC for ICSS [2022-01-01 to 2022-07-31]

    The predictive performance of imaging change scoring system before and after neoadjuvant chemotherapy (ICSS)

  2. AUC for BNCISS [2022-01-01 to 2022-07-31]

    The predictive performance of before neoadjuvant chemotherapy imaging scoring system (BNCISS)

Secondary Outcome Measures

  1. overall survival [2010-01-01 to 2022-07-31]

    3 year overall survival

  2. disease free survival [2010-01-01 to 2022-07-31]

    3 year disease free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Gastric Surgery Fuzhou Fujian China

Sponsors and Collaborators

  • Fujian Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang-Ming Huang, Prof., Principal Investigator, Fujian Medical University
ClinicalTrials.gov Identifier:
NCT05465512
Other Study ID Numbers:
  • FMUUH-001
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chang-Ming Huang, Prof., Principal Investigator, Fujian Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022