Trial of Excision Versus Photodynamic Therapy in the Trea... | NCT00472706

Studies
Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease

NCT00472706

Sponsor

Catharina Ziekenhuis Eindhoven

Status

Terminated

Last Update Posted

May 13, 2010Estimated

Enrollment

65Actual

Phase

Phase 4

Conditions

Bowen's Disease

Interventions

excision
Photodynamic therapy

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

May 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study stopped because of disappointing inclusion rates

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Feb 2009Estimated

Completion Date

Feb 2010Actual

First Submitted Date

May 10, 2007

First Submission Date that Met QC Criteria

May 10, 2007

First Posted Date

May 14, 2007Estimated

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

May 12, 2010

Last Update Posted Date

May 13, 2010Estimated

Name	Class
Erasmus Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy.

Detailed Description

The study is a randomized clinical trial in which two treatment options for Bowen's disease, excision and photodynamic therapy, are compared on recurrence rate, cosmesis en expenses.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Excision	Procedure: excision
2	Active Comparator	Photodynamic therapy	Procedure: Photodynamic therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
excision	Procedure	excision 3 mm margin	1
Photodynamic therapy

Measure	Description	Time Frame
recurrence rate		two years

Measure	Description	Time Frame
cosmetic outcome		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Histological proven Bowen's disease on scalp, face, trunk, arms and legs
Informed Consent

Exclusion Criteria:

Recurrent Bowen's disease
Anogenital or subungual Bowe's disease
Other skin malignancy in the same area
Porphyria

Accepts Healthy Volunteers

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
Annette Verzijl, MD	Catharina hospital/Erasmus MC	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001913	Bowen's Disease

Ancestor Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010778	Photochemotherapy

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D010789	Phototherapy

Browse Leaves

Not provided

Browse Branches

Not provided