Oral SquamousRaP E ToCNCT04821128
Radio/Pathological Evaluation of Tongue Cancer Infiltration
An observational study of Oral Squamous and Cell Carcinoma, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Squamous, Cell Carcinoma
- What is being tested?
- Radiologic and pathological review.
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2020to 27 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- patients chirurgically treated for an OSCC
- T1 T2 T3
- CT scanner in their medical file
Who cannot join
- T4
- R+ résection
- Artefacts on CT scanner
Trial locations and contacts
1 site in 1 country.
Leonard MEGUERDITCHIAN, MD contact
France1 site, 1 recruiting
- Recruiting
Croix rousse hospital
Lyon, 69004
Leonard MEGUERDITCHIAN, MD, 4 26 10 90 10 ext. +33, leonard.meguerditchian-hoffmeyer@chu-lyon.fr
About this study
Official title: 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.
- Conditions
- Oral Squamous, Cell Carcinoma
- Being tested
- Radiologic and pathological review.
- Keywords
- DOI, Infiltration, Oral cavity cancer, OSCC, Tongue cancer, CT scanner
- Medical subject headings
- Mouth Neoplasms, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiologic and pathological review.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Radiologic and pathological review. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The outcome will be measured at the inclusion of the patient in the current study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start27 Nov 2020
- Primary completion27 Nov 2020
- Study completion27 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral SquamousStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821128
- Sponsor's protocol ID
- 242
- Acronym
- RaP E ToC
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04821128
- Acronym / sponsor ID
- RaP E ToC / 242
- Conditions
- Oral Squamous, Cell Carcinoma
- Keywords
- DOI, Infiltration, Oral cavity cancer, OSCC, Tongue cancer, CT scanner
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 27 May 2021 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who improved surgical treatment for oral cavity cancer | – | Other: Radiologic and pathological review.T1 T2 and T3 OSCC tumor, patients who have a recent evaluation cervico thoracic scanner in their medical files. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients chirurgically treated for an OSCC
- T1 T2 T3
- CT scanner in their medical file
Key exclusion criteria (3 listed)
- T4
- R+ résection
- Artefacts on CT scanner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients who improved surgical treatment for oral cavity cancer |
Primary outcome
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.
Time frame: The outcome will be measured at the inclusion of the patient in the current study.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard MEGUERDITCHIAN, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous and Cell Carcinoma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonard MEGUERDITCHIAN, MD (6 10 46 17 70 ext. +33, leonard.meguerditchian-hoffmeyer@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: The outcome will be measured at the inclusion of the patient in the current study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.