NCT00390351

Brief Summary

We will do systematic and functional assessment of non-melanoma skin cancer including precancerous lesions by OCT imaging and other diagnostic methods. The systematic assessment will be comparison of clinical diagnosis, histopathology, OCT images, spectrophotometry and high frequency ultrasound of non-melanoma skin cancer Functional exploration of non-melanoma skin cancer is done with Doppler-OCT and polarization-sensitive-OCT.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2006

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

February 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 19, 2006

Status Verified

October 1, 2006

First QC Date

October 18, 2006

Last Update Submit

October 18, 2006

Conditions

Skin Neoplasms

Keywords

Optical coherence tomography

Interventions

optical coherence tomographyDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients above the age of 18 years with primary non-melanoma skin cancer NMSC or precancerous lesions from the Dermatology Department, and the Plastic Surgery Department at Roskilde Hospital, and from office based dermatologist in Roskilde County. Patients will only be recruited after informed consent.

You may not qualify if:

  • Pregnancy.
  • To avoid the potential bias of scar tissue in the OCT images we will not include OCT images from recurrent NMSC in this study.
  • Patients will be excluded from the study if they are not able to give an informed consent. Staff from the Dermatology, Internal Medicine and Plastic Surgery Departments at RAS cannot be included in the phase I/phase 2 study.
  • Gender: both
  • Age limits: 18- no max

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Roskilde Hospital

Roskilde, Roskilde, DK-4000, Denmark

RECRUITING

Dept. of Dermatology, Copenhagen University

Dk-4000 Roskilde, 4000, Denmark

SUSPENDED

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Mette Mogensen, MD

    Dept. of Dermatology, Roskilde Hospital

    PRINCIPAL INVESTIGATOR

  • Gregor BE Jemec, MD, DMSc

    Dept. of Dermatology, Roskilde Hospital

    STUDY DIRECTOR

Central Study Contacts

Mette Mogensen, MD

CONTACT

+45 4732 2116rsmmog@ra.dk

Gregor BE Jemec, MD, DMSc

CONTACT

+45 4732 2022rsgrj@ra.dk

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2006

First Posted

October 19, 2006

Study Start

February 1, 2006

Study Completion

July 1, 2008

Last Updated

October 19, 2006

Record last verified: 2006-10

Locations

DK(2)