The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiomics-based Models for the Prediction of Pathological Response to Neoadjuvant Therapy in Gastric and Gastroesophageal Cancer (RADI-S)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06044961
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Agnes Annamaria, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Identifying predictors of response to neoadjuvant therapy in gastric and gastro-oesophageal cancer early in the history of the disease would ensure optimal treatment planning.

The study aims to apply radiomics for the prediction of response to neoadjuvant therapy.


Condition or disease Intervention/treatment
Patients With Locally Advanced Carcinoma of the Stomach and Oesophagogastric Junction Radiation: CT scan

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Radiomics-based Models for the Prediction of Pathological Response to Neoadjuvant Therapy in Gastric and Gastroesophageal Cancer
Study Start Date : January 1, 2005
Actual Primary Completion Date : August 30, 2022
Actual Study Completion Date : November 15, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Radiation: CT scan
    All pre-operative CT scan collected

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Use of radiomics [ Time Frame: 1 month ]
    Apply radiomics for predicting response to neoadjuvant therapy.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with locally advanced stomach cancer
Criteria

Inclusion Criteria:

  • Patients with locally advanced stomach cancer undergoing neoadjuvant chemotherapy and gastrectomy between January 2005 and August 2022

Exclusion Criteria:

  • Siewert 1 tumors;
  • Patients who have received neoadjuvant with the addition of a biological drug;
  • Patients who have received radiotherapy;
  • Patients without staging CT scan or with insufficient image quality in terms of phases performed, pixel spacing, slide thickness (mandatorily: > 5 mm) or artefacts.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Agnes Annamaria, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT06044961    
Other Study ID Numbers: 5297
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Agnes Annamaria, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
stomach cancer
esophagogastric junction.
locally advanced carcinoma of the stomach
radiomics
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases