Mass SpectroscopySpecTumNCT05104619
Spectroscopic Analysis of Tongue Tumor Samples.
An observational study of Mass Spectroscopy and Molecular Profile, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mass Spectroscopy, Molecular Profile, Surgical Margins
- What is being tested?
- tongue surgery
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2021to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- age : 18 years and older
- squamous cell carcinoma of the tongue
- surgical resection as first-line treatment
- tumor classification T1 to T4.
Who cannot join
- metastatic disease
- neoadjuvant therapies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Amiens
Amiens, Picardie, 80000
Christophe ATTENCOURT, MD, 03 22 66 87 66, attencourt.christophe@chu-amiens.fr
About this study
Official title: 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.
- Conditions
- Mass Spectroscopy, Molecular Profile, Surgical Margins, Squamous Cell Carcinoma, Oral Cavity, Tongue
- Being tested
- tongue surgery
- Keywords
- mass spectroscopy, molecular profile, surgical margins, squamous cell carcinoma, oral cavity, tongue
- Medical subject headings
- Margins of Excision, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tongue surgeryProcedure or surgery
In squamous cell carcinoma of the tongue, complete surgical resection of the tumor
| Study group | Role | What they receive |
|---|---|---|
| tumor samples | (SCC of the tongue) Receives: Procedure: tongue surgery | |
| healthy tissues | Not described Receives: Procedure: tongue surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor cells detection in tongue tumor with SpiderMass technique
Tumor cells detection in tongue tumor with SpiderMass technique
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start10 Mar 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mass SpectroscopyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104619
- Sponsor's protocol ID
- s PI2020_843_0156
- Acronym
- SpecTum
- Status last verified
- Jun 2026
- First submitted
- 12 Oct 2021
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Tumor Tissues From the Oral Cavity by SpiderMassTM Spectroscopy
- ClinicalTrials.gov ID
- NCT05104619
- Acronym / sponsor ID
- SpecTum / s PI2020_843_0156
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Université de Lille
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tumor samples | – | Procedure: tongue surgery(SCC of the tongue) |
| healthy tissues | – | Procedure: tongue surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- age : 18 years and older
- squamous cell carcinoma of the tongue
- surgical resection as first-line treatment
- tumor classification T1 to T4.
Key exclusion criteria (2 listed)
- metastatic disease
- neoadjuvant therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tongue surgeryIn squamous cell carcinoma of the tongue, complete surgical resection of the tumor | Procedure or surgery | healthy tissues, tumor samples |
Primary outcome
Tumor cells detection in tongue tumor with SpiderMass technique
Time frame: 1 year
Tumor cells detection in tongue tumor with SpiderMass technique
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mass Spectroscopy and Molecular Profile, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe ATTENCOURT, MD (03 22 66 87 66, attencourt.christophe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor cells detection in tongue tumor with SpiderMass technique (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.