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

Basal Cell Carcinoma Clinical Trial

— DOCTOBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05608902
• Other study ID #: DermatOCT1
• Status: Completed
• Start date: September 6, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2024
• Source: Centre Hospitalier William Morey - Chalon sur Saône
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 31, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Tomography, Optical Coherence

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier William Morey - Chalon sur Saône	Chalon sur Saône	Saône-et-Loire

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier William Morey - Chalon sur Saône

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathological analysis of basal cell carcinoma with dynamic full-field optical coherence tomography	Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and characterize the usual basal cell carcinoma, comprising basaloid cells with a thin pale cytoplasm surrounding round or oval nuclei with a rough granulated chromatin pattern, palisade arrangement, artificially created slits, rather chaotic internal arrangement, mitoses and necrosis ; but also to identify the different sub-types of basal cell carcinoma (nodular, superficial, infiltrating, scleroderma).	Outcome measure is assessed 15 days following skin biopsy or resection
Secondary	Histopathological analysis of healthy skin with dynamic full-field optical coherence tomography	Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify the normal structures of the skin (meaning not affected by carcinoma), i.e. the different layers of the skin (epidermis, dermis and subcutaneous tissue) and the skin appendages (hair follicles and glands), also to recognize the different cells and components (keratinocytes, melanocytes, Langerhans cells, Merkel celles and collagen) and underlayers (stratum corneum, stratum granulosum, stratum spinosum, stratum basale, epidermal cretes, dermo-hypodermic junction, papillary dermis and reticularis dermis).	Outcome measure is assessed 15 days following skin biopsy or resection