Basal Cell CarcinomasRNA-OCT-BCCNCT06813833
Transcriptomic Analysis and Optical Coherence Tomography Combined for Patients With Basal Cell Carcinoma
An observational study of Basal Cell Carcinomas, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The goal of this observational study is to learn if tape strip for transcriptomic (RNA) analysis and optical coherence tomography (OCT) combined can optimize noninvasive management of basal cell carcinoma (BCC) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinomas
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Jan 2025to 31 May 2025
- 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: Patients with histology verified basal cell carcinoma
Who may be able to join
- Patients > 18 years with clinical suspicious BCC for inclusion in the study and BCC histopathology diagnosis for inclusion in our analysis.
Who cannot join
- Patients with a BCC in areas not amenable to OCT (e.g., around the eye).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Image Markers and Transcriptome Profiles: an Exploratory Study of Optical Coherence Tomography and Tape Strips for Basal Cell Carcinoma
The goal of this observational study is to learn if tape strip for transcriptomic (RNA) analysis and optical coherence tomography (OCT) combined can optimize noninvasive management of basal cell carcinoma (BCC) patients.
The main question of the study is to examine if the combination of these two techniques, transcriptomic and OCT, can improve noninvasive detection of human BCCs.
All included patients will undergo 1) an OCT scan and 2) a tape strip collection for transcriptomic analysis from the same BCC.
- Conditions
- Basal Cell Carcinomas
- Keywords
- Basal Cell Carcinoma, Optical Coherence Tomography, Transcriptomics, Tape strip, Skin Cancer, Keratinocyte Carcinoma
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between tape strip and OCT
The association between BCC-specific image marker profiles from OCT and BCC-specific transcriptomic profiles from tape strips, in histopathologically confirmed BCC patients.
Measured: Single time point at baseline examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start6 Jan 2025
- Primary completion30 Apr 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomasStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Merete Haedersdal, Bispebjerg Hospital
- Investigators
- Merete Haedersdal, Professor, MD, DMSc, PhD, Principal investigator, Department of Dermatology, Copenhagen University Hospital - Bispebjerg, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813833
- Sponsor's protocol ID
- H-24060543
- Other IDs
- H-24060543
- Acronym
- RNA-OCT-BCC
- Status last verified
- Sep 2025
- First submitted
- 3 Feb 2025
- Last updated
- 19 Sep 2025
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Markers and Transcriptome Profiles: an Exploratory Study of Optical Coherence Tomography and Tape Strips for Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06813833
- Acronym / sponsor ID
- RNA-OCT-BCC / H-24060543
- Conditions
- Basal Cell Carcinomas
- Keywords
- Basal Cell Carcinoma, Optical Coherence Tomography, Transcriptomics, Tape strip, Skin Cancer, Keratinocyte Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 7 Feb 2025 (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.
The goal of this observational study is to learn if tape strip for transcriptomic (RNA) analysis and optical coherence tomography (OCT) combined can optimize noninvasive management of basal cell carcinoma (BCC) patients.
The main question of the study is to examine if the combination of these two techniques, transcriptomic and OCT, can improve noninvasive detection of human BCCs.
All included patients will undergo 1) an OCT scan and 2) a tape strip collection for transcriptomic analysis from the same BCC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histology verified basal cell carcinoma
Key inclusion criteria (1 listed)
- Patients > 18 years with clinical suspicious BCC for inclusion in the study and BCC histopathology diagnosis for inclusion in our analysis.
Key exclusion criteria (1 listed)
- Patients with a BCC in areas not amenable to OCT (e.g., around the eye).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between tape strip and OCT
Time frame: Single time point at baseline examination
The association between BCC-specific image marker profiles from OCT and BCC-specific transcriptomic profiles from tape strips, in histopathologically confirmed BCC patients.
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 19 Sep 2025.
- 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.
Merete Haedersdal, Professor, MD, DMSc, PhD principal investigator
Department of Dermatology, Copenhagen University Hospital - Bispebjerg, Copenhagen, Denmark
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 Carcinomas, run by Bispebjerg Hospital at 1 site in Denmark.
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 1 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 19 Sep 2025. 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 Denmark. 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?
Association between tape strip and OCT (time frame: Single time point at baseline examination). 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 19 Sep 2025.