NCT06813833

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

February 3, 2025

Last Update Submit

September 16, 2025

Conditions

Basal Cell Carcinomas

Keywords

Basal Cell CarcinomaOptical Coherence TomographyTranscriptomicsTape stripSkin CancerKeratinocyte Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Single time point at baseline examination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with histology verified basal cell carcinoma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tape strips for transcriptomic analysis of BCC and healthy skin

MeSH Terms

Conditions

Carcinoma, Basal CellSkin Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Merete Haedersdal, Professor, MD, DMSc, PhD

    Department of Dermatology, Copenhagen University Hospital - Bispebjerg, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief Physician, DMSc, PhD

Study Record Dates

First Submitted

February 3, 2025

First Posted

February 7, 2025

Study Start

January 6, 2025

Primary Completion

April 30, 2025

Study Completion

May 31, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

DK(1)