Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study (DOCTOBA)

NCT ID: NCT05608902

Last Updated: 2024-01-03

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

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-06

Study Completion Date

2023-03-31

Brief Summary

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Basal cell carcinoma (BCC) are the most frequent skin cancers. Their incidence is constantly increasing. BCC diagnosis is first clinically suspected and then confirmed following histological examination of either a skin biopsy or the excisional specimen. Surgery is the first-line treatment and some procedures (notably Mohs surgery) require extemporaneous histological analysis of the edges to ensure a complete excision. Such on-site histopathological examination can be time consuming and associated with decreased sensitivity. Skin imaging techniques have already been tested to overcome these limitations and seem promising. Although some of them - such as confocal microscopy - are already even used in vivo, there is to date no report of the use of full-field optical coherence tomography for the diagnosis of BCC.

The DOCTOBA study intends to describe direct histopathological examination of fresh skin biopsy or excisional specimen with dynamic full-field optical coherence tomography.

Detailed Description

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Conditions

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Basal Cell Carcinoma Tomography, Optical Coherence

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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DOCTOBA cohort

Patients \> 18 years of age with suspected basal cell carcinoma requiring biopsy or skin resection in the dermatology department

Dynamic full-field optical coherence tomography analysis of skin biopsy or resection

Intervention Type OTHER

Dynamic full-field optical coherence tomography analysis of skin biopsy or resection in the dermatology department before conventional histopathological analysis

Interventions

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Dynamic full-field optical coherence tomography analysis of skin biopsy or resection

Dynamic full-field optical coherence tomography analysis of skin biopsy or resection in the dermatology department before conventional histopathological analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- patient \> 18 years of age who received skin biopsy or excision of basal cell carcinoma suspected lesion between start study date and primary completion date

Exclusion Criteria

* inability to perform dynamic full-field optical coherence tomography observation at the moment of skin biopsy
* diagnosis of basal cell carcinoma disproved
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier William Morey - Chalon sur Saône

OTHER

Sponsor Role lead

Responsible Party

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Thomas Maldiney

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Maldiney

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier William Morey - Chalon sur Saône

Locations

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Centre Hospitalier William Morey - Chalon sur Saône

Chalon-sur-Saône, Saône-et-Loire, France

Site Status

Countries

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France

Other Identifiers

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DermatOCT1

Identifier Type: -

Identifier Source: org_study_id

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