- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03319251
Biomarker Database Registry for Photodynamic Therapy
Biomarkers of Clinical Responsiveness to Photodynamic Therapy
Study Overview
Status
Conditions
Detailed Description
Patients who have been scheduled to receive PDT in our noninvasive cutaneous oncology clinics will be given written information prior to their visit, including a copy of the Informed Consent (IC) that describes the purpose of the study. If the patient indicates that he/she is interested, the physician or study nurse will review the IC with the patient on the day of PDT and answer all questions. After the patient signs the IC, the patient will have their blood drawn by a caregiver who has completed PTS Phlebotomy Training.
DNA samples will be stored in a locked minus 80 degree ultrafreezer, in Dr. Maytin's laboratory (room ND4-25A in the Lerner Research Institute). The samples will be maintained for up to 10 years.
Blood sample tubes and data sheets in the laboratory will be labeled with a code consisting of the first 5 digits of the patient's 8-digit MRN along with the date that the phlebotomy was performed (i.e. the date of the blood draw). This should ensure anonymity of the data while preventing mistakes when linking the laboratory results to the correct patient. Study personnel with password-protected access to the database registry will use the code to unequivocally identify the subject's file within the Oracle database and thereby enter the subject's laboratory results into the proper data field.
The Informed Consent document informs the subject that he/she can withdraw permission for use of their samples at any time, and explains how to do this by contacting the Principal Investigator (PI) in writing.
Information will not be disclosed to third party outside of Cleveland Clinic for research purposes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Males or females, at least 18 years of age
- Patient has nonhypertrophic actinic keratosis, at least 10 AK lesions present on the face, scalp, forearms, chest, or legs at the time of PDT treatment
Exclusion Criteria:
- taking doxycline, a photosensitizer
- using topical retinoids, since these can exacerbate the post-PDT erythema reaction
- pregnant
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actinic Keratosis (AK) clearance
Time Frame: at 3 months post-treatment
|
Change in AK lesions present at 3 months post-PDT treatment
|
at 3 months post-treatment
|
Vitamin D levels
Time Frame: At baseline, which is the day of PDT treatment
|
Vitamin D level (25-hydroxy-cholecalciferol) measured in serum
|
At baseline, which is the day of PDT treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Allele polymorphisms in the gene of the Vitamin D receptor (VDR)
Time Frame: At baseline, which is the day of PDT treatment
|
Identify the allele combination present at VDR locus
|
At baseline, which is the day of PDT treatment
|
Allele polymorphisms in the gene promoter of thymidylate synthase (TS) enzyme
Time Frame: At baseline, which is the day of PDT treatment
|
Identify the allele combination present at TS locus
|
At baseline, which is the day of PDT treatment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bullock TA, Negrey J, Hu B, Warren CB, Hasan T, Maytin EV. Significant improvement of facial actinic keratoses after blue light photodynamic therapy with oral vitamin D pretreatment: An interventional cohort-controlled trial. J Am Acad Dermatol. 2022 Jul;87(1):80-86. doi: 10.1016/j.jaad.2022.02.067. Epub 2022 Mar 18.
- Heusinkveld LE, Bullock TA, Negrey J, Warren CB, Maytin EV. Sandpaper curettage: A simple method to improve PDT outcomes for actinic keratosis. Photodiagnosis Photodyn Ther. 2022 Dec;40:103050. doi: 10.1016/j.pdpdt.2022.103050. Epub 2022 Aug 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-1615
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Actinic Keratosis
-
Dolorgiet GmbH & Co. KGd.s.h. statistical services GmbH; CenTrial GmbHCompletedActinic Keratosis Olsen Grade I/IIGermany
-
Cosmetique Active InternationalNot yet recruiting
-
Centre Dermatologique du RoyCompleted
-
Encube Ethicals Pvt. Ltd.CBCC Global ResearchCompleted
-
University of California, DavisActive, not recruiting
-
Northwestern UniversityWithdrawn
-
Tulane UniversityMayne Pharma International Pty LtdTerminatedActinic KeratosesUnited States
-
Medical University of ViennaTerminatedActinic KeratosesAustria
-
University Hospital RegensburgGerman Research FoundationCompleted
-
St Vincent's University Hospital, IrelandCompleted