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Clinical Trials in Italy / NCT04878783
Active, not recruiting Observational

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

NCT04878783 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Roma La Sapienza
Phase
Observational
Started
2019-12-20
Last updated
2024-05-09

Condition(s) studied

Gastric CancerAdenocarcinoma of the Stomach

Investigational drug(s) / intervention(s)

CT scan

CT scan: Patients undergoing CT scan staging for gastric and EJ junction cancer + perioperative chemotherapy (FLOT regimen) , CT scan re-staging and radical gastrectomy or esophagogastrectomy will be enrolled in the study

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Predictive performance of radiomics analysis on the pre-treatment CT scan. — 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.

Trial sites (5)

FacilityCityRegionStatus
University of Padova Padova Italy
Link Campus University Roma Italy
Giovanni Maria Garbarino Roma Italy
University of Verona Verona Italy
Amsterdam UMC location University of Amsterdam Amsterdam North Holland

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Genomic and Dietary Aspects in Gastric Cancer Risk Starting soon
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04878783 on ClinicalTrials.gov ↗ ← All trials in Italy