Basal Cell CarcinomaNCT06342297
Dermatoscopy Guided Resection for Skin Cancer
A study testing Dermatoscopy in people with Basal Cell Carcinoma and Cutaneous Squamous Cell Carcinoma, run by Region Örebro County at 1 site in Sweden.
Trial summary
In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Surgical Margin
- What is being tested?
- Dermatoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jan 2024to 14 Jan 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patients with primary suspected or verified basal cell carcinoma or cutaneous cell carcinoma
Who cannot join
- Recurrent tumours
- Previous radiotherapy of the tumour area
- If the patient cannot understand the study i nformation
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Örebro University Hospital
Örebro, 70375
Örebro U Hospital, 0729655663, fredrik.landstrom@regionorebrolan.se
About this study
Official title: Dermatoscopy Guided Resection Margins in Basal Cell Carcinoma and Cutaneos Squamous Cell Carcinoma
In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report.
Read the detailed description
In basal cell carcinoma and especially cutaneous squamous cell carcinoma the prognosis is very good if the tumour is radically removed in the primary resection. In this study we propose that the use of dermatoscopy in deciding the surgical margins can increase the proportion of radically removed tumours. In this randomized clinical trial the use of dermatoscopy in deciding the surgical margins in patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma is assessed. The outcome measure is radical/non radical resection of the lateral margins. In the control group dematoscopy is not used in deciding the surgical margin. 400 patients with suspected or verified BCC or cSCC will be included, 200 in each group.
- Being tested
- Dermatoscopy
- Keywords
- Dermatoscopy
- Medical subject headings
- Carcinoma, Basal Cell, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermatoscopyDevice
Dermatoscopy used in decision of surgical margin before resection of basal cell carcinoma or cutaneous squamous cell carcinoma
| Study group | Role | What they receive |
|---|---|---|
| No dermatoscopy | No intervention | Dermatoscopy not used in decision of surgical margin |
| Dermatoscopy | Experimental | Dermatoscopy is used in decision of surgical margin Receives: Device: Dermatoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathology resection side margin (radical/not radical)
If the side margins in the pathology report is radical or not
Measured: Pathology report usually within two weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start14 Jan 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion14 Jan 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik Landström, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342297
- Sponsor's protocol ID
- OLL-1003043
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermatoscopy Guided Resection Margins in Basal Cell Carcinoma and Cutaneos Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06342297
- Acronym / sponsor ID
- OLL-1003043
- Keywords
- Dermatoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 14 Jan 2026 (estimated)
- First posted
- 2 Apr 2024 (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.
In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report.
Detailed description
In basal cell carcinoma and especially cutaneous squamous cell carcinoma the prognosis is very good if the tumour is radically removed in the primary resection. In this study we propose that the use of dermatoscopy in deciding the surgical margins can increase the proportion of radically removed tumours. In this randomized clinical trial the use of dermatoscopy in deciding the surgical margins in patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma is assessed. The outcome measure is radical/non radical resection of the lateral margins. In the control group dematoscopy is not used in deciding the surgical margin. 400 patients with suspected or verified BCC or cSCC will be included, 200 in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No dermatoscopy | No intervention | –Dermatoscopy not used in decision of surgical margin |
| Dermatoscopy | Experimental | Device: DermatoscopyDermatoscopy is used in decision of surgical margin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with primary suspected or verified basal cell carcinoma or cutaneous cell carcinoma
Key exclusion criteria (3 listed)
- Recurrent tumours
- Previous radiotherapy of the tumour area
- If the patient cannot understand the study i nformation
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 |
|---|---|---|
| DermatoscopyDermatoscopy used in decision of surgical margin before resection of basal cell carcinoma or cutaneous squamous cell carcinoma | Device | Dermatoscopy |
Primary outcome
Pathology resection side margin (radical/not radical)
Time frame: Pathology report usually within two weeks after surgery
If the side margins in the pathology report is radical or not
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermatoscopy in people with Basal Cell Carcinoma and Cutaneous Squamous Cell Carcinoma, run by Region Örebro County at 1 site in Sweden.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Apr 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fredrik Landström, MD, PhD (019 602 14 68 ext. 0046, fredrik.landstrom@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathology resection side margin (radical/not radical) (time frame: Pathology report usually within two weeks after surgery). 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 2 Apr 2024.