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

NCT05608902 | Completed

• 1 other identifier: DermatOCT1
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma; Tomography, Optical Coherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Histopathological analysis of healthy skin with dynamic full-field optical coherence tomography

  Outcome measure is assessed 15 days following skin biopsy or resection

Study Arms (1)

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

Interventions

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

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

DOCTOBA cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient \> 18 years of age who received skin biopsy or excision of basal cell carcinoma suspected lesion

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier William Morey - Chalon sur Saône: lead

Study Sites (1)

Centre Hospitalier William Morey - Chalon sur Saône

Chalon-sur-Saône, Saône-et-Loire, 71100, France

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Thomas Maldiney

  Centre Hospitalier William Morey - Chalon sur Saône

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 8, 2022
• Study Start: September 6, 2022
• Primary Completion: January 26, 2023
• Study Completion: March 31, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

FR (1)