Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

RADIOMICS AND MOLECULAR EXPRESSION PREDICTIVE MODEL FOR ESOPHAGO-GASTRIC JUNCTION AND GASTRIC CANCER TRG

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04878783
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : May 7, 2021
Sponsor:
Collaborator:
Andrea Laghi
Information provided by (Responsible Party):
Giovanni Maria Garbarino, University of Roma La Sapienza

Brief 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.

Condition or disease Intervention/treatment
Gastric Cancer Adenocarcinoma of the Stomach Diagnostic Test: CT scan

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: CT SCAN-BASED RADIOMICS AND MOLECULAR EXPRESSION PREDICTIVE MODEL TO ASSESS TUMOR REGRESSION GRADE FOLLOWING PERIOPERATIVE CHEMOTHERAPY IN ESOPHAGO-GASTRIC JUNCTION AND GASTRIC CANCER
Actual Study Start Date : December 20, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 10, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: 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
    Other Names:
    • FLOT chemotherapy
    • Radical Gastrectomy with D2 Lymphadenectomy
    • Radical Esophagogastrectomy with D2 Lymphadenectomy


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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

  3. 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


Biospecimen Retention:   Samples With DNA
Gastrectomy or esophagogastrectomy specimen


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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878783


Contacts
Layout table for location contacts
Contact: Giovanni M GARBARINO, M.D +393334693359 giovannimaria.garbarino@uniroma1.it

Locations
Layout table for location information
Italy
Giovanni Maria Garbarino Recruiting
Roma, Italy, 00191
Contact: giovanni m garbarino, M.D.    +393334693359    giovannimaria.garbarino@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Andrea Laghi
Layout table for additonal information
Responsible Party: Giovanni Maria Garbarino, M.D., University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04878783    
Other Study ID Numbers: URomLS2022
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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 Giovanni Maria Garbarino, University of Roma La Sapienza:
radiomics
molecular expression
perioperative chemotherapy
FLOT
gastric cancer
esophago-gastric junction cancer
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