NCT04821128

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2021

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

March 25, 2021

Last Update Submit

March 26, 2021

Conditions

Keywords

DOIInfiltrationOral cavity cancerOSCCTongue cancerCT scanner

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

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.

Interventions

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.

Patients who improved surgical treatment for oral cavity cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • R+ résection
  • Artefacts on CT scanner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix rousse hospital

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Mouth NeoplasmsTongue Neoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesTongue Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 29, 2021

Study Start

November 27, 2020

Primary Completion

November 27, 2020

Study Completion

May 27, 2021

Last Updated

March 29, 2021

Record last verified: 2021-03

Locations