Organ TransplantsNCT00365521
Prophylactic Photodynamic Therapy to Organ Transplant Patients
A study testing Photodynamic Therapy in people with Organ Transplants, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Organ Transplants
- What is being tested?
- Photodynamic Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2009to not given
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Organ transplant recipients.
- Age 40 years or older.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital
Copenhagen, Copenhagen NV, 2400
Merete Hædersdal, +45 35 31 60 02, mhaedersdal@dadlnet.dk
About this study
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.
- Conditions
- Organ Transplants
- Being tested
- Photodynamic Therapy
- Keywords
- Organ transplant patients receiving immunosuppressive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic TherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Merete Hædersdal, MD, PhD, DrMedSci, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365521
- Sponsor's protocol ID
- KF-01-314759
- Status last verified
- May 2008
- First submitted
- 15 Aug 2006
- Last updated
- 2 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Photodynamic Therapy to Organ Transplant Patients
- ClinicalTrials.gov ID
- NCT00365521
- Acronym / sponsor ID
- KF-01-314759
- Conditions
- Organ Transplants
- Keywords
- Organ transplant patients receiving immunosuppressive therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Apr 2009
- First posted
- 17 Aug 2006 (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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Organ transplant recipients.
- Age 40 years or older.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Photodynamic Therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2008.
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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.
Merete Hædersdal, MD, PhD, DrMedSci principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photodynamic Therapy in people with Organ Transplants, run by Bispebjerg Hospital at 1 site in Denmark.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 2 Jun 2008. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merete Hædersdal, MD, PhD, DrMedSci (+45 35316002, mhaedersdal@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 2 Jun 2008.