Transcriptomic Analysis and Optical Coherence Tomography Combined for Patients With Basal Cell Carcinoma (RNA-OCT-BCC)

September 16, 2025 updated by: Merete Haedersdal, Bispebjerg Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Department of Dermatology, Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with histology verified basal cell carcinoma

Description

Inclusion Criteria:

  • Patients > 18 years with clinical suspicious BCC for inclusion in the study and BCC histopathology diagnosis for inclusion in our analysis.

Exclusion Criteria:

  • Patients with a BCC in areas not amenable to OCT (e.g., around the eye).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single time point at baseline examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Merete Haedersdal, Professor, MD, DMSc, PhD, Department of Dermatology, Copenhagen University Hospital - Bispebjerg, Copenhagen, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2025

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24060543 (Other Identifier: The Regional Research Ethics Committees)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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