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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05608902
Acronym
DOCTOBA
Enrollment
22
Registered
2022-11-08
Start date
2022-09-06
Completion date
2023-03-31
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma, Tomography, Optical Coherence

Brief 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.

Interventions

OTHERDynamic 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

Sponsors

Centre Hospitalier William Morey - Chalon sur Saône
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Histopathological analysis of basal cell carcinoma with dynamic full-field optical coherence tomographyOutcome measure is assessed 15 days following skin biopsy or resectionProvide 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).

Secondary

MeasureTime frameDescription
Histopathological analysis of healthy skin with dynamic full-field optical coherence tomographyOutcome measure is assessed 15 days following skin biopsy or resectionProvide 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026