Basal Cell CarcinomaDOCTOBANCT05608902
Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study (DOCTOBA)
An observational study of Basal Cell Carcinoma and Tomography, Optical Coherence, run by Centre Hospitalier William Morey - Chalon sur Saône at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Tomography, Optical Coherence
- What is being tested?
- Dynamic full-field optical coherence tomography analysis of skin biopsy or resection
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient > 18 years of age who received skin biopsy or excision of basal cell carcinoma suspected lesion
Who may be able to join
- 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
Who cannot join
- inability to perform dynamic full-field optical coherence tomography observation at the moment of skin biopsy
- diagnosis of basal cell carcinoma disproved
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier William Morey - Chalon sur Saône
Chalon-sur-Saône, Saône-et-Loire, 71100
About this study
Official title: Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study
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.
- Being tested
- Dynamic full-field optical coherence tomography analysis of skin biopsy or resection
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic full-field optical coherence tomography analysis of skin biopsy or resectionOther
Dynamic full-field optical coherence tomography analysis of skin biopsy or resection in the dermatology department before conventional histopathological analysis
| Study group | Role | What they receive |
|---|---|---|
| DOCTOBA cohort | Patients > 18 years of age with suspected basal cell carcinoma requiring biopsy or skin resection in the dermatology department Receives: Other: Dynamic full-field optical coherence tomography analysis of skin biopsy or resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: Outcome measure is assessed 15 days following skin biopsy or resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start6 Sep 2022
- Primary completion26 Jan 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier William Morey - Chalon sur Saône
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Maldiney, Centre Hospitalier William Morey - Chalon sur Saône
- Investigators
- Thomas Maldiney, Principal investigator, Centre Hospitalier William Morey - Chalon sur Saône
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608902
- Sponsor's protocol ID
- DermatOCT1
- Acronym
- DOCTOBA
- Status last verified
- Jan 2024
- First submitted
- 21 Oct 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study
- ClinicalTrials.gov ID
- NCT05608902
- Acronym / sponsor ID
- DOCTOBA / DermatOCT1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier William Morey - Chalon sur SaôneUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOCTOBA cohort | – | Other: Dynamic full-field optical coherence tomography analysis of skin biopsy or resectionPatients > 18 years of age with suspected basal cell carcinoma requiring biopsy or skin resection in the dermatology department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient > 18 years of age who received skin biopsy or excision of basal cell carcinoma suspected lesion
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- inability to perform dynamic full-field optical coherence tomography observation at the moment of skin biopsy
- diagnosis of basal cell carcinoma disproved
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic full-field optical coherence tomography analysis of skin biopsy or resectionDynamic full-field optical coherence tomography analysis of skin biopsy or resection in the dermatology department before conventional histopathological analysis | Other | DOCTOBA cohort |
Primary outcome
Histopathological analysis of basal cell carcinoma with dynamic full-field optical coherence tomography
Time frame: 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).
1 secondary outcome
Histopathological analysis of healthy skin with dynamic full-field optical coherence tomography
Time frame: Outcome measure is assessed 15 days following skin biopsy or resection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Maldiney principal investigator
Centre Hospitalier William Morey - Chalon sur Saône
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma and Tomography, Optical Coherence, run by Centre Hospitalier William Morey - Chalon sur Saône at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathological analysis of basal cell carcinoma with dynamic full-field optical coherence tomography (time frame: Outcome measure is assessed 15 days following skin biopsy or resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.