Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study (DOCTOBA)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| DOCTOBA cohort Patients > 18 years of age with suspected basal cell carcinoma requiring biopsy or skin resection in the dermatology department |
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
|
Outcome Measures
Primary Outcome Measures
- Histopathological analysis of basal cell carcinoma with dynamic full-field optical coherence tomography [Outcome measure is assessed 15 days following skin biopsy or resection]
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).
Secondary Outcome Measures
- Histopathological analysis of healthy skin with dynamic full-field optical coherence tomography [Outcome measure is assessed 15 days following skin biopsy or resection]
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).
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier William Morey - Chalon sur Saône | Chalon sur Saône | Saône-et-Loire | France | 71100 |
Sponsors and Collaborators
- Centre Hospitalier William Morey - Chalon sur Saône
Investigators
- Principal Investigator: Thomas Maldiney, Centre Hospitalier William Morey - Chalon sur Saône
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DermatOCT1