Carcinoma, Basal CellNCT00218868
Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunwald-giemsa Stained Tissue Smear
An observational study of Carcinoma, Basal Cell and Porokeratosis, Disseminated Superficial Actinic, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 105 years
- Conditions the study is for
- Carcinoma, Basal Cell, Porokeratosis, Disseminated Superficial Actinic
- What is being tested?
- Skin scrape
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2000to Nov 2007
- 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 0 to 105 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 50 BCC and 28 AK histologically verified lesions, from 41 and 25 patients, respectively
Who may be able to join
- Histologically verified basal call carcinoma and actinic keratosis
Who cannot join
- Morphea form of basal cell carcinoma. Pigmented form of basal cell carcinoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunvald-giemsa Stained Cutaneous Tissue Smear in Relation to Photodynamic Therapy
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.
- Being tested
- Skin scrape
- Keywords
- Cytodiagnosis, Skin Scrape, Touch Imprint, Papanicolaou, May-Grunvald-Giemsa
- Medical subject headings
- Carcinoma, Basal Cell, Porokeratosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin scrapeProcedure or surgery
scrape cytology using two different cytological staining techniques, and additional touch imprint cytology compared with histopathology of superficial basal cell carcinoma and actinic keratosis
| Study group | Role | What they receive |
|---|---|---|
| skin scrape | Not described Receives: Procedure: Skin scrape |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2000
- Primary completionFeb 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eidi Christensen, MD, Principal investigator, St. Olav, University Hospital, Trondheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218868
- Sponsor's protocol ID
- EC-001
- Status last verified
- Dec 2023
- First submitted
- 20 Sep 2005
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17916094
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunvald-giemsa Stained Cutaneous Tissue Smear in Relation to Photodynamic Therapy
- ClinicalTrials.gov ID
- NCT00218868
- Acronym / sponsor ID
- EC-001
- Keywords
- Cytodiagnosis, Skin Scrape, Touch Imprint, Papanicolaou, May-Grunvald-Giemsa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Feb 2006 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- 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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skin scrape | – | Procedure: Skin scrape |
Who may qualify
- Ages
- 0 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 50 BCC and 28 AK histologically verified lesions, from 41 and 25 patients, respectively
Key inclusion criteria (1 listed)
- Histologically verified basal call carcinoma and actinic keratosis
Key exclusion criteria (1 listed)
- Morphea form of basal cell carcinoma. Pigmented form of basal cell carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin scrapescrape cytology using two different cytological staining techniques, and additional touch imprint cytology compared with histopathology of superficial basal cell carcinoma and actinic keratosis | Procedure or surgery | skin scrape |
Primary outcome
Not reported in the source record.
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 29 Dec 2023.
- Results publication: PubMed 17916094Christensen 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.
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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.
Eidi Christensen, MD principal investigator
St. Olav, University Hospital, Trondheim
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 Carcinoma, Basal Cell and Porokeratosis, Disseminated Superficial Actinic, run by Norwegian University of Science and Technology at 1 site in Norway.
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 29 Dec 2023. 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 Norway. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00218868, which also lists 1 linked publication.
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 29 Dec 2023.