Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination

Study Overview
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Brief Summary
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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

Official Title
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Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination (Pilot Study)

Conditions
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Squamous Cell Carcinoma of Head and Neck, Basal Cell Carcinoma of Skin

Intervention / Treatment
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* Other: microscopy confocal (Histolog Scanner)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microscopy confocal<br> | Other: microscopy confocal (Histolog Scanner)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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margin surgical, confocal microscopy, conventional histopathology (H&E)