Spectroscopic Analysis of Tongue Tumor Samples. (SpecTum)

February 7, 2023 updated by: Centre Hospitalier Universitaire, Amiens

Prospective Analysis of Tumor Tissues From the Oral Cavity by SpiderMassTM Spectroscopy

In squamous cell carcinoma of the tongue, complete surgical resection of the tumor generally represents the primary treatment strategy. Among factors determining the disease prognostic, the surgical margins status is essential for the continued management of the patient, with or without complementary therapies. Generally, surgical margins are defined using visual and tactile elements. Unfortunately, in 15 to 30 percent of cases, they are defined as positive after histopathological examination, on average 5 to 7 days post-surgery.

Techniques have recently been developed to analyze the cancerous and non-cancerous nature of tissues, using the spectral properties of tumor cells. SpiderMass™ is an instrument equipped with a probe for tissue micro-sampling and real-time molecular profile analysis. It is thus ultimately a tool for anatomopathological decision support, for diagnosis and prognosis of the disease. Used in the operating room, SpiderMass™ could also become an innovative surgical tool to precisely define cancerous areas in situ and the margins status in intraoperative conditions.

Based on the principle of artificial intelligence, the SpiderMass™ machine must initially learn to recognize pathological tissues versus healthy. This project aims to accomplish this first phase of machine learning for squamous cell carcinoma of the tongue.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Patients treated in the Maxillofacial Surgery Department of the CHU Amiens-Picardie for a squamous cell carcinoma of the tongue and for whom the first-line treatment is surgical resection

Description

Inclusion Criteria:

  • age : 18 years and older
  • squamous cell carcinoma of the tongue
  • surgical resection as first-line treatment
  • tumor classification T1 to T4.

Exclusion Criteria:

  • metastatic disease
  • neoadjuvant therapies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
tumor samples
(SCC of the tongue)
Procedure: tongue surgery
In squamous cell carcinoma of the tongue, complete surgical resection of the tumor
healthy tissues
Procedure: tongue surgery
In squamous cell carcinoma of the tongue, complete surgical resection of the tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor cells detection in tongue tumor with SpiderMass technique
Time Frame: 1 year
Tumor cells detection in tongue tumor with SpiderMass technique
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

Université de Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (ACTUAL)

November 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s PI2020_843_0156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Squamous Cell Carcinoma

Clinical Trials on tongue surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe