Radiomics-based Models for the Prediction of Pathological... | NCT06044961

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2005

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Nov 15, 2022Actual

First Submitted Date

Sep 13, 2023

First Submission Date that Met QC Criteria

Sep 13, 2023

First Posted Date

Sep 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2023

Last Update Posted Date

Sep 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Agnes Annamaria, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Name	Type	Description	Arm Group Labels	Other Names
CT scan	Radiation	All pre-operative CT scan collected

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Use of radiomics	Apply radiomics for predicting response to neoadjuvant therapy.	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with locally advanced stomach cancer

Sampling Method

Probability Sample

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases