Spectroscopic Analysis of Tongue Tumor Samples.

NCT05104619 | Unknown

• 1 other identifier: s PI2020_843_0156
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Mass Spectroscopy; Molecular Profile; Surgical Margins; Squamous Cell Carcinoma; Oral Cavity; Tongue

Keywords

mass spectroscopy; molecular profile; surgical margins; squamous cell carcinoma; oral cavity; tongue

Outcome Measures

Primary Outcomes (1)

• Tumor cells detection in tongue tumor with SpiderMass technique

  Tumor cells detection in tongue tumor with SpiderMass technique

  1 year

Study Arms (2)

tumor samples

(SCC of the tongue)

Procedure: tongue surgery

healthy tissues

Procedure: tongue surgery

Interventions

tongue surgery PROCEDURE

In squamous cell carcinoma of the tongue, complete surgical resection of the tumor

healthy tissues; tumor samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated in the Maxillofacial Surgery Department of the CHU Amiens-Picardie for a squamous cell carcinoma of the tongue and for whom the first-line treatment is surgical resection

You may qualify if:

• age : 18 years and older
• squamous cell carcinoma of the tongue
• surgical resection as first-line treatment
• tumor classification T1 to T4.

You may not qualify if:

• metastatic disease
• neoadjuvant therapies

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Université de Lille: collaborator

Study Sites (1)

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue samples will be taken from the tumor and the non-tumor areas. Surgical specimens will be taken in a fresh state immediately after surgery, by an anatomopathologist and a pathological anatomy technician. The sample will be analyzed under standard conditions. Two sites will be selected macroscopically (including a tumor area, a dysplasia area, and a non-tumor area).

MeSH Terms

Conditions

Margins of Excision; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Central Study Contacts

Christophe ATTENCOURT, MD

CONTACT

03 22 66 87 66; attencourt.christophe@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 3, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)