Prophylactic Photodynamic Therapy to Organ Transplant Pat... | NCT00365521

Studies
Prophylactic Photodynamic Therapy to Organ Transplant Patients

NCT00365521

Sponsor

Bispebjerg Hospital

Status

Unknown status

Last Update Posted

Jun 2, 2008Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Organ Transplants

Interventions

Photodynamic Therapy

Countries

Denmark

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 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 15, 2006

First Submission Date that Met QC Criteria

Aug 16, 2006

First Posted Date

Aug 17, 2006Estimated

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 30, 2008

Last Update Posted Date

Jun 2, 2008Estimated

Description Module

Brief Summary

To evaluate a possible prophylactic efficacy of photodynamic therapy on the incidence of non-melanoma skin cancer, actinic keratoses, warts and keratoses in recently organ transplanted recipients.

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

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Photodynamic Therapy	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Organ transplant recipients.
Age 40 years or older.

Exclusion Criteria:

Patients younger than 40 years and older than 70 years.
Clinical signs of skin cancer, actinic keratoses or warts at the time of inclusion.
Previous photodynamic therapy to the skin areas investigated.
Pregnancy or breast feeding patients.
Patients with porphyria.
Patients with a tendency to produce hypertrophic scars or keloids.
Patients with known allergy to Metvix.
Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients etc.).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Merete Hædersdal, MD, PhD, DrMedSci	Contact	+45 35316002		mhaedersdal@dadlnet.dk

Overall Officials

Name	Affiliation	Role
Merete Hædersdal, MD, PhD, DrMedSci	Bispebjerg Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Copenhagen	Copenhagen NV	2400	Denmark

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