- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05104619
Spectroscopic Analysis of Tongue Tumor Samples. (SpecTum)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christophe ATTENCOURT, MD
- Phone Number: 03 22 66 87 66
- Email: attencourt.christophe@chu-amiens.fr
Study Locations
-
-
Picardie
-
Amiens, Picardie, France, 80000
- Recruiting
- Centre Hospitalier Universitaire D'Amiens
-
Contact:
- Christophe ATTENCOURT, MD
- Phone Number: 03 22 66 87 66
- Email: attencourt.christophe@chu-amiens.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
tumor samples
(SCC of the tongue)
|
In squamous cell carcinoma of the tongue, complete surgical resection of the tumor
|
|
healthy tissues
|
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
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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