Radio/Pathological Evaluation of Tongue Cancer Infiltration (RaP E ToC)

An Evaluation of the Radio/Pathological Correlation of Depth Of Invasion for Oral Squamous Cell Carcinoma, a Retrospective Study in a University Hospital in Lyon

The aim of the study is to assess the good correlation and prediction of the DOI for the post-operative pathological results and prognosis.

Study Overview

• Status: Recruiting
• Conditions: Cell Carcinoma; Oral Squamous
• Intervention / Treatment: Other: Radiologic and pathological review.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Leonard MEGUERDITCHIAN, MD; Phone Number: +33 6 10 46 17 70; Email: leonard.meguerditchian-hoffmeyer@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Croix Rousse Hospital
    • Contact: Leonard MEGUERDITCHIAN, MD; Phone Number: +33 4 26 10 90 10; Email: leonard.meguerditchian-hoffmeyer@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population will include all the patients chirurgically treated for an OSCC for 2014 to 2019, who have a pre operativ scanner at least in their medical file.

We will exclude the T4, the patients with very artefacted exams, and those with R+ resections.

Description

Inclusion Criteria:

• patients chirurgically treated for an OSCC
• T1 T2 T3
• CT scanner in their medical file

Exclusion Criteria:

• T4
• R+ résection
• Artefacts on CT scanner

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who improved surgical treatment for oral cavity cancer; T1 T2 and T3 OSCC tumor, patients who have a recent evaluation cervico thoracic scanner in their medical files.	Other: Radiologic and pathological review.; We will analyse the pre operative scannographic and MRI (if available) images, and the post operative pathological analyses. The scanners will be reviewed by 2 well trained clinicians (one head and neck radiologist and one head and neck surgeon). Then we will analyse the correlation between the radiological and the pathological analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome will be the measure of the correlation of the depth of invasion on the radiological pre operative images and of the pathological analyses on the resection piece.	With a Bland Altman analysis we will assess the good correlation between the pre and post operatory mesures of the depth of invasion in the oral squamous cell carcioma	The outcome will be measured at the inclusion of the patient in the current study.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Actual): November 27, 2020
• Study Completion (Anticipated): May 27, 2021

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Tongue cancer; Infiltration; Oral cavity cancer; OSCC; DOI; CT scanner
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: 242

Drug and device information, study documents

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