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NCT04878783Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 9 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
138 (actual)
First submitted
6 May 2021
Start date
20 Dec 2019
Primary completion date
1 Oct 2024
Lead sponsor
University of Roma La Sapienza
NCT number
NCT04878783

What you commit to

  • Study type: Observational
  • Participants enrolled: 138
  • From 20 Dec 2019 to the primary completion date, 1 Oct 2024
  • 5 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • Siewert I EGJ tumor
  • Exploratory laparoscopy with positive cytology on the peritoneal lavage or evidence of peritoneal carcinosis

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Padova
Coordinator of this site? Confirm its status
PadovaItalyUnknown status
Giovanni Maria Garbarino
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Link Campus University
Coordinator of this site? Confirm its status
RomaItalyUnknown status
University of Verona
Coordinator of this site? Confirm its status
VeronaItalyUnknown status
Amsterdam UMC location University of Amsterdam
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.