NCT05617469

Brief Summary

The early noninvasive screening of patients suitable for neoadjuvant chemotherapy (NCT) is essential for personalized treatment in locally advanced gastric cancer (LAGC). The aim of this study was to develop and visualized a radio-clinical biomarker from pretreatment oversampled CT images to predict the response and prognosis to NCT in LAGC patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

November 8, 2022

Last Update Submit

November 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tumor regression grade

    Tumor regression grade

    3 months

Interventions

develop and visualized a radio-clinical signatures from pretreatment oversampled CT images to predict the neoadjuvant chemotherapy response and prognosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with histologically confirmed GC/esophagogastric junction cancer (EGJC) who received NCT prior to surgical resection

You may qualify if:

  • \) patients with GC/EGJC confirmed by pathological examination; 2) patients who underwent D2 lymphadenectomy; 3) patients who received at least two cycles of preoperative chemotherapy; 4) patients with negative resection margins; and 5) patients with complete CT image data and clinical data.

You may not qualify if:

  • \) patients unable to undergo D2 radical gastrectomy after neoadjuvant therapy; and 2) patients with incomplete CT images and clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 15, 2022

Study Start

July 1, 2022

Primary Completion

January 30, 2023

Study Completion

July 31, 2023

Last Updated

November 15, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Due to the privacy of patients, the data related to patients cannot be available for public access but can be obtained from the corresponding author on reasonable request approved by the institutional review board of all enrolled centers.

Locations