Carcinoma, Basal CellNCT00237107
Debulking Effect of Curretage on Basal Cell Carcinomas - a Histological Assessment.
A study testing Curretage in people with Carcinoma, Basal Cell, run by Norwegian University of Science and Technology.
Trial summary
The aim of this study was to compare histologically observed tumour infitration of basal cell carcinoma (bcc) lesions before and after curretage.A significant reduction of tumour depth would enable further bcc's included for superficial non-invasive treatment modalities such as topical photodynamic therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- Curretage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Dec 2004
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- bcc with tumour depth two mm.or more
Who cannot join
- bcc tumours smaller than three mm in mean diameter.
About this study
Official title: Relation of Basal Cell Carcinoma Tumour Thickness, Histologically Estimated, in Punch Biopsies Performed Before and After Curretage.
The aim of this study was to compare histologically observed tumour infitration of basal cell carcinoma (bcc) lesions before and after curretage.A significant reduction of tumour depth would enable further bcc's included for superficial non-invasive treatment modalities such as topical photodynamic therapy.
- Conditions
- Carcinoma, Basal Cell
- Being tested
- Curretage
- Keywords
- Cytoreduction Surgical Procedures, Curretage, Photochemotherapy
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurretageProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| curettage | Experimental | Not described Receives: Procedure: Curretage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of tumour thickness 0,5mm or more after curretage
Measured: 1 hour
Secondary outcomes (1)
Comparison of tumour thickness in punch biopsies performed on referral, before and after curretage.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startApr 2002
- Primary completionDec 2004
- Study completionDec 2004
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT00237107
- Sponsor's protocol ID
- EC-003
- Status last verified
- Jul 2016
- First submitted
- 10 Oct 2005
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Christensen E, Mork C, Foss OA. Pre-treatment deep curettage can significantly reduce tumour thickness in thick Basal cell carcinoma while maintaining a favourable cosmetic outcome when used in combination with topical photodynamic therapy. J Skin Cancer. 2011;2011:240340. doi: 10.1155/2011/240340. Epub 2011 Nov 15.
PubMed 22191035
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Basal Cell Carcinoma Tumour Thickness, Histologically Estimated, in Punch Biopsies Performed Before and After Curretage.
- ClinicalTrials.gov ID
- NCT00237107
- Acronym / sponsor ID
- EC-003
- Conditions
- Carcinoma, Basal Cell
- Keywords
- Cytoreduction Surgical Procedures, Curretage, Photochemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 12 Oct 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 aim of this study was to compare histologically observed tumour infitration of basal cell carcinoma (bcc) lesions before and after curretage.A significant reduction of tumour depth would enable further bcc's included for superficial non-invasive treatment modalities such as topical photodynamic therapy.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| curettage | Experimental | Procedure: Curretage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bcc with tumour depth two mm.or more
Key exclusion criteria (1 listed)
- bcc tumours smaller than three mm in mean diameter.
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 |
|---|---|---|
| Curretage | Procedure or surgery | curettage |
Primary outcome
Reduction of tumour thickness 0,5mm or more after curretage
Time frame: 1 hour
1 secondary outcome
Comparison of tumour thickness in punch biopsies performed on referral, before and after curretage.
Time frame: 3 months
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 19 Jul 2016.
- Results publication: PubMed 22191035Christensen E, Mork C, Foss OA. Pre-treatment deep curettage can significantly reduce tumour thickness in thick Basal cell carcinoma while maintaining a favourable cosmetic outcome when used in combination with topical photodynamic therapy. J Skin Cancer. 2011;2011:240340. doi: 10.1155/2011/240340. Epub 2011 Nov 15.
- Individual participant dataSharing planned: No
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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
Questions about this trial
What is this clinical trial studying?
A study testing Curretage in people with Carcinoma, Basal Cell, run by Norwegian University of Science and Technology.
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 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Reduction of tumour thickness 0,5mm or more after curretage (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00237107, 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 19 Jul 2016.