Debulking Effect of Curretage on Basal Cell Carcinomas -... | NCT00237107

Studies
Debulking Effect of Curretage on Basal Cell Carcinomas - a Histological Assessment.

NCT00237107

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Jul 19, 2016Estimated

Enrollment

36Actual

Phase

Not Applicable

Conditions

Carcinoma, Basal Cell

Interventions

Curretage

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

Dec 2004Actual

Completion Date

Dec 2004Actual

First Submitted Date

Oct 10, 2005

First Submission Date that Met QC Criteria

Oct 10, 2005

First Posted Date

Oct 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2016

Last Update Posted Date

Jul 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Label	Type	Description	Intervention Names
curettage	Experimental		Procedure: Curretage

Name	Type	Description	Arm Group Labels	Other Names
Curretage	Procedure		curettage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of tumour thickness 0,5mm or more after curretage		1 hour

Secondary Outcomes

Measure	Description	Time Frame
Comparison of tumour thickness in punch biopsies performed on referral, before and after curretage.		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

bcc with tumour depth two mm.or more

Exclusion Criteria:

bcc tumours smaller than three mm in mean diameter.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eidi Christensen, MD	St. Olav University Hospital, Trondheim	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22191035	Result	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.

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms