Spectroscopic Analysis of Tongue Tumor Samples.

NCT ID: NCT05104619

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

tumor samples

(SCC of the tongue)

tongue surgery

Intervention Type PROCEDURE

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

healthy tissues

tongue surgery

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tongue surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Université de Lille

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christophe ATTENCOURT, MD

Role: CONTACT

03 22 66 87 66

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christophe ATTENCOURT, MD

Role: primary

03 22 66 87 66

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

s PI2020_843_0156

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.