Squamous Cell Carcinoma of Head and NeckHISTOBLOCNCT05935995
Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination
A study testing microscopy confocal (Histolog Scanner) in people with Squamous Cell Carcinoma of Head and Neck and Basal Cell Carcinoma of Skin, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
Study to evaluate the use of confocal microscopy for detecting resection margins in patients undergoing surgery for basal cell carcinoma of skin and squamous Cell Carcinoma of Head and Neck Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck, Basal Cell Carcinoma of Skin
- What is being tested?
- microscopy confocal (Histolog Scanner)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2023to 21 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Adult patient ≥18 years old
- Squamous cell or basal cell tumor (1 to 4 cm) of mucous or cutaneous origin.
- Patient whose surgical indication has been validated in a consultation meeting
- Patients with scheduled surgery
- WHO< or =2
- ASA < 3
- Patient affiliated to the social security system
- Patient has understood, signed and dated the consent form.
Who cannot join
- History of irradiation in the surgical area
- Women who are pregnant or who are breast-feeding.
- Persons deprived of their liberty or under guardianship (including curators)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination (Pilot Study)
Study to evaluate the use of confocal microscopy for detecting resection margins in patients undergoing surgery for basal cell carcinoma of skin and squamous Cell Carcinoma of Head and Neck
- Being tested
- microscopy confocal (Histolog Scanner)
- Keywords
- margin surgical, confocal microscopy, conventional histopathology (H&E)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Basal Cell, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microscopy confocal (Histolog Scanner)Other
Surgical margins of tumor samples will be examined by conventional histopathology (H\&E) and confocal microscopy (Histolog® scanner, SamanTree Medical, Switzerland).
Depending on the histopathological result obtained between the two methods, the patient may benefit directly from early surgery if the experimental result confirms the presence of positive margins (excluding the learning curve).
A learning curve will be established over the first fifteen surgeries, enabling surgical teams to gain experience and systematize specimen flattening. This learning curve will also enable reference images to be produced. The procedure will be carried out by the surgeon and the pathologist in the operating room during this phase.
| Study group | Role | What they receive |
|---|---|---|
| Microscopy confocal | Experimental | Not described Receives: Other: microscopy confocal (Histolog Scanner) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of Confocal Microscopy Diagnosis Compared to Gold Standard
The concordance of intraoperative diagnosis between the two methods will be assessed by the condition of the margins of surgical specimens. Diagnostic accuracy will be measured by the sensitivity and specificity of confocal microscopy, using conventional histology reports from extemporaneous examination as the gold standard.
- negative margins (absence of tumour cells) ;
- positive margins (presence of tumour cells).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start28 Nov 2023
- Primary completion21 Jun 2025
- Study completion21 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GILLES DOLIVET, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935995
- Sponsor's protocol ID
- 2023-A00818-37
- Acronym
- HISTOBLOC
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gravante G, Leroux A, Garbar C, Henry L, Cortese S, Beulque E, Mastronicola R, Dolivet G. Intraoperative Ex Vivo Confocal Microscopy for Surgical Margin Assessment in Squamous Cell and Basal Cell Carcinoma (HISTOBLOC): Protocol for a Prospective Monocentric Pilot Study. JMIR Res Protoc. 2026 Sep 9;15:e91436. doi: 10.2196/91436.
PubMed 42714336
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination (Pilot Study)
- ClinicalTrials.gov ID
- NCT05935995
- Acronym / sponsor ID
- HISTOBLOC / 2023-A00818-37
- Keywords
- margin surgical, confocal microscopy, conventional histopathology (H&E)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 21 Jun 2025 (actual)
- Study completion
- 21 Jun 2026 (actual)
- First posted
- 7 Jul 2023 (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.
Study to evaluate the use of confocal microscopy for detecting resection margins in patients undergoing surgery for basal cell carcinoma of skin and squamous Cell Carcinoma of Head and Neck
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microscopy confocal | Experimental | Other: microscopy confocal (Histolog Scanner) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patient ≥18 years old
- Squamous cell or basal cell tumor (1 to 4 cm) of mucous or cutaneous origin.
- Patient whose surgical indication has been validated in a consultation meeting
- Patients with scheduled surgery
- WHO< or =2
Key exclusion criteria (3 listed)
- History of irradiation in the surgical area
- Women who are pregnant or who are breast-feeding.
- Persons deprived of their liberty or under guardianship (including curators)
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 |
|---|---|---|
| microscopy confocal (Histolog Scanner)Surgical margins of tumor samples will be examined by conventional histopathology (H\&E) and confocal microscopy (Histolog® scanner, SamanTree Medical, Switzerland). Depending on the histopathological result obtained between the two methods, the patient may benefit directly from early surgery if the experimental result confirms the presence of positive margins (excluding the learning curve). A learning curve will be established over the first fifteen surgeries, enabling surgical teams to gain experience and systematize specimen flattening. This learning curve will also enable reference images to be produced. The procedure will be carried out by the surgeon and the pathologist in the operating room during this phase. | Other | Microscopy confocal |
Primary outcome
Sensitivity and Specificity of Confocal Microscopy Diagnosis Compared to Gold Standard
Time frame: 1 day
The concordance of intraoperative diagnosis between the two methods will be assessed by the condition of the margins of surgical specimens. Diagnostic accuracy will be measured by the sensitivity and specificity of confocal microscopy, using conventional histology reports from extemporaneous examination as the gold standard. * negative margins (absence of tumour cells) ; * positive margins (presence of tumour cells).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Derived from this study: PubMed 42714336Gravante G, Leroux A, Garbar C, Henry L, Cortese S, Beulque E, Mastronicola R, Dolivet G. Intraoperative Ex Vivo Confocal Microscopy for Surgical Margin Assessment in Squamous Cell and Basal Cell Carcinoma (HISTOBLOC): Protocol for a Prospective Monocentric Pilot Study. JMIR Res Protoc. 2026 Sep 9;15:e91436. doi: 10.2196/91436.
- 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. This study is not recruiting at the moment.
GILLES DOLIVET, MD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microscopy confocal (Histolog Scanner) in people with Squamous Cell Carcinoma of Head and Neck and Basal Cell Carcinoma of Skin, run by Institut de Cancérologie de Lorraine 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 1 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of Confocal Microscopy Diagnosis Compared to Gold Standard (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935995, which also lists 1 linked publication.
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 1 Sep 2026.