Spectroscopic Analysis of Tongue Tumor Samples.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tongue surgery.
- Who it may be relevant to
- Registry conditions: Mass Spectroscopy, Molecular Profile, Surgical Margins, Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Analysis of Tumor Tissues From the Oral Cavity by SpiderMassTM Spectroscopy
Overview
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.
Interventions
- Procedure tongue surgery
In squamous cell carcinoma of the tongue, complete surgical resection of the tumor
Primary outcome measures
- Tumor cells detection in tongue tumor with SpiderMass technique [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Centre Hospitalier Universitaire d'Amiens — Amiens
Identifiers
NCT: NCT05104619 · s PI2020_843_0156