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

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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

Tracking Information
First Submitted Date May 6, 2021
First Posted Date May 7, 2021
Last Update Posted Date May 7, 2021
Actual Study Start Date December 20, 2019
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2021)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 6, 2021)
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title RADIOMICS AND MOLECULAR EXPRESSION PREDICTIVE MODEL FOR ESOPHAGO-GASTRIC JUNCTION AND GASTRIC CANCER TRG
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
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.
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 [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
Gastrectomy or esophagogastrectomy specimen
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.
Condition
  • Gastric Cancer
  • Adenocarcinoma of the Stomach
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 6, 2021)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 10, 2022
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Giovanni M GARBARINO, M.D +393334693359 giovannimaria.garbarino@uniroma1.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04878783
Other Study ID Numbers URomLS2022
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Giovanni Maria Garbarino, University of Roma La Sapienza
Study Sponsor University of Roma La Sapienza
Collaborators Andrea Laghi
Investigators Not Provided
PRS Account University of Roma La Sapienza
Verification Date May 2021