NCT05465512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

July 12, 2022

Last Update Submit

July 15, 2022

Conditions

Keywords

tumor regression graderadiomicsneoadjuvant chemotherapyadvanced gastric cancerchemotherapy benefit

Outcome Measures

Primary Outcomes (2)

  • AUC for ICSS

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

    2022-01-01 to 2022-07-31

  • AUC for BNCISS

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

    2022-01-01 to 2022-07-31

Secondary Outcomes (2)

  • overall survival

    2010-01-01 to 2022-07-31

  • disease free survival

    2010-01-01 to 2022-07-31

Study Arms (2)

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

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

Interventions

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).

good response to neoadjuvant chemotherapy (GRNC)poor response to neoadjuvant chemotherapy (PRNC)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastric Surgery

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Hualong Zheng

    291167038@qq.com

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 19, 2022

Study Start

January 4, 2022

Primary Completion

June 1, 2022

Study Completion

July 10, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations