NCT00218868

Brief Summary

The purpose of this study is to compare and evaluate the diagnostic performance of scrape cytology using two different cytological staining techniques, and to evaluate additional touch imprint cytology with that of histopathology of superficial basal cell carcinoma and actinic keratosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 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 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

6.1 years

First QC Date

September 20, 2005

Last Update Submit

December 28, 2023

Conditions

Carcinoma, Basal CellPorokeratosis, Disseminated Superficial Actinic

Keywords

CytodiagnosisSkin ScrapeTouch ImprintPapanicolaouMay-Grunvald-Giemsa

Study Arms (1)

skin scrape

Procedure: Skin scrape

Interventions

Skin scrapePROCEDURE

scrape cytology using two different cytological staining techniques, and additional touch imprint cytology compared with histopathology of superficial basal cell carcinoma and actinic keratosis

skin scrape

Eligibility Criteria

Age0 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 BCC and 28 AK histologically verified lesions, from 41 and 25 patients, respectively

You may qualify if:

  • Histologically verified basal call carcinoma and actinic keratosis

You may not qualify if:

  • Morphea form of basal cell carcinoma. Pigmented form of basal cell carcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olav University Hospital

Trondheim, 7006, Norway

Location

Related Publications (1)

  • Christensen E, Bofin A, Gudmundsdottir I, Skogvoll E. Cytological diagnosis of basal cell carcinoma and actinic keratosis, using Papanicolaou and May-Grunwald-Giemsa stained cutaneous tissue smear. Cytopathology. 2008 Oct;19(5):316-22. doi: 10.1111/j.1365-2303.2007.00483.x. Epub 2007 Oct 4.

    PMID: 17916094RESULT

MeSH Terms

Conditions

Carcinoma, Basal CellPorokeratosis

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Eidi Christensen, MD

    St. Olav, University Hospital, Trondheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

January 1, 2000

Primary Completion

February 1, 2006

Study Completion

November 1, 2007

Last Updated

December 29, 2023

Record last verified: 2023-12

Locations

NO(1)