Spectroscopic Analysis of Tongue Tumor Samples.

Recruiting

• Conditions: Surgical Margins; Squamous Cell Carcinoma; Mass Spectroscopy; Oral Cavity; Tongue; Molecular Profile
• Interventions: Procedure: tongue surgery

• Registration Number: NCT05104619
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-03
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy tissues	tongue surgery	-
tumor samples	tongue surgery	(SCC of the tongue)

Primary Outcome Measures

Name	Time	Method
Tumor cells detection in tongue tumor with SpiderMass technique	1 year	Tumor cells detection in tongue tumor with SpiderMass technique

Trial Locations

Locations (1)

Centre Hospitalier Universitaire d'Amiens; 🇫🇷 Amiens, Picardie, France