Spectroscopic Analysis of Tongue Tumor Samples.

Squamous Cell Carcinoma Clinical Trial

— SpecTum  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05104619
• Other study ID #: s PI2020_843_0156
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: October 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Christophe ATTENCOURT, MD
• Phone: 03 22 66 87 66
• Email: attencourt.christophe[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Oral Cavity
• Squamous Cell Carcinoma

Intervention

Procedure:
• tongue surgery
In squamous cell carcinoma of the tongue, complete surgical resection of the tumor

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Amiens	Amiens	Picardie

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Université de Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor cells detection in tongue tumor with SpiderMass technique	Tumor cells detection in tongue tumor with SpiderMass technique	1 year