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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
microscopy confocal (Histolog Scanner)
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Squamous Cell Carcinoma of Head and Neck focused on measuring margin surgical, confocal microscopy, conventional histopathology (H&E)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Gilles Dolivet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microscopy confocal

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
June 27, 2023
Last Updated
July 26, 2023
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT05935995
Brief Title
Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination
Acronym
HISTOBLOC
Official Title
Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination (Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Head and Neck, Basal Cell Carcinoma of Skin
Keywords
margin surgical, confocal microscopy, conventional histopathology (H&E)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microscopy confocal
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
microscopy confocal (Histolog Scanner)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity and Specificity of Confocal Microscopy Diagnosis Compared to Gold Standard
Description
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).
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JEAN LOUIS MERLIN, PharmD, PhD
Phone
+33383656062
Email
jl.merlin@nancy.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GILLES DOLIVET, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gilles Dolivet
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GILLES DOLIVET, MD
Phone
+33383598446
Email
g.dolivet@nancy.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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