Radiomics and Molecular Expression Predictive Model for Esophago-Gastric Junction and Gastric Cancer TRG

May 8, 2024 updated by: Giovanni Maria Garbarino, University of Roma La Sapienza

CT Scan-Based Radiomics and Molecular Expression Predictive Model to Assess Tumor Regression Grade Following Perioperative Chemotherapy in Esophago-Gastric Junction and Gastric Cancer

The aim of this study is to develop a CT scan-based radiomics predictive model about tumor regression grade (TRG) in patients with esophago-gastric junction (EGJ) ang gastric cancer undergoing perioperative chemotherapy. The molecular expression of the neoplasms will be evaluated to assess its association with the TRG and the radiomic features.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

• To compare the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan.

A non-good response (non-GR) has shown to be predictable with texture analysis on the pre-treatment CT scan.

Therefore, we hypothesize that texture analysis could let to identify the good response patients.

• To find correlation between the molecular expression of the tumor and the radiomics features.

Texture analysis on the pre-chemotherapy CT scan founded that entropy and compactness were higher and uniformity lower in responders. Nonetheless the association between radiomics features and molecular expression has not been investigated yet.

Therefore, we hypothesize to add some others radiomics signatures to the analysis and to find an association with the molecular expression.

• To find correlation between the molecular expression of the tumor and the TRG.

MSI gastric cancer has been shown to be less responsive to preoperative chemotherapy.

Therefore, we hypothesize to confirm this result.

Study Type

Observational

Enrollment (Actual)

138

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

  • Italy
      • Padova, Italy, 35128
        • University of Padova
      • Roma, Italy, 00189
        • Giovanni Maria Garbarino
      • Roma, Italy, 00165
        • Link Campus University
      • Verona, Italy
        • University of Verona
  • Netherlands
    • Nord-Holland
      • Amsterdam, Nord-Holland, Netherlands, 1081 HV
        • Amsterdam UMC location University of Amsterdam

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with cT2-T4a, cN0-N3, M0 gastric or EGJ cancer who undergo FLOT perioperative chemotherapy followed by radical surgical resection.

Description

Inclusion Criteria:

  • Patients with histologically proven adenocarcinoma of the EGJ (Siewert II-III) or stomach.
  • Preoperative staging: cT2-T4a, cN0-N3, M0.
  • Patients >18 years old.
  • Patients undergoing perioperative chemotherapy with Docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil (FLOT).

Exclusion Criteria:

  • Siewert I EGJ tumor
  • Patients undergoing preoperative radiotherapy.
  • Absence of both pre and post-chemotherapy CT-scan.
  • Patients with tumor progression during preoperative chemotherapy.
  • Patients undergoing other neoadjuvant chemotherapy regimen different from FLOT
  • Exploratory laparoscopy with positive cytology on the peritoneal lavage or evidence of peritoneal carcinosis

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive performance of radiomics analysis on the pre-treatment CT scan.
Time Frame: 2 months
Comparing the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of the radiomics features with the molecular expression of the tumor.
Time Frame: 2 months

Texture analysis on the pre-chemotherapy CT scan founded that entropy and compactness were higher and uniformity lower in responders. Nonetheless the association between radiomics features and molecular expression has not been investigated yet.

Therefore, we hypothesize to add some others radiomics signatures to the analysis and to find an association with the molecular expression.
2 months
Evaluation of the association between TRG and the molecular expression of the tumor.
Time Frame: 2 months
Investigate if the molecular expression of the tumor can influence the TRG
2 months
Association between radiomics and molecular expression in regards to long-term outcomes
Time Frame: 5 years
Analysis of the 3 and 5y DFS and OS of patients with the radiomics and molecular expression profile
5 years

Collaborators and Investigators

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

Sponsor

University of Roma La Sapienza

Collaborators

Andrea Laghi

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)

December 20, 2019

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URomLS2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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