Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Medical Imaging (RECTOMICS)

Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Magnetic Resonance Imaging, Contrast Injection Computed Tomography and Positron Emission Tomography at 18-FDG in Locally Advanced Rectal Cancer

In patient with complete pathological response, surgery could be omitted without compromising progression-free or overall survival. A powerful prediction model is needed to guide management of this population.

Radiomics features provide complementary information about tumor heterogenity.

The aim of the investigators is to develop a model combining clinical and radiomic criteria able to predict complete pathological response.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• France
  • Brest, France
    • CHRU de Brest (Morvan)
  • Bretagne
    • Quimper, Bretagne, France, 29000
      • Centre Hospitalier de Cornouaille
  • Saint Herblain
    • Nantes, Saint Herblain, France, 44800
      • ICO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with locally advanced rectal cancer

Description

Inclusion Criteria:

• locally advanced rectal cancer
• patients who received concomitant radio-chemotherapy followed by surgery
• pre-therapeutic MRI and CT-scan dicom available

Exclusion Criteria:

• age under 18 yo
• lack of MRI or CT-scan

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
training population; patients from which we will develop the prediction model
testing population; patients on whom we will test the prediction model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of the complete response (pCR) to neoadjuvant chemoradiotherapy	defined as the absence of tumor residue on the surgical specimen, ypT0N0	TO = Immediately after biopsy and extension evaluation.

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: locally advanced rectal cancer; radiomic
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: RECTOMICS (29BRC20.0027)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning one year and ending five years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No