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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05104619
Other study ID # s PI2020_843_0156
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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