Biomarker Database Registry for Photodynamic Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03319251|
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : July 17, 2020
|Condition or disease|
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 :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Biomarkers of Clinical Responsiveness to Photodynamic Therapy|
|Actual Study Start Date :||October 6, 2017|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||November 30, 2022|
- Actinic Keratosis (AK) clearance [ Time Frame: at 3 months post-treatment ]Change in AK lesions present at 3 months post-PDT treatment
- Vitamin D levels [ Time Frame: At baseline, which is the day of PDT treatment ]Vitamin D level (25-hydroxy-cholecalciferol) measured in serum
- 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
- 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319251
|Contact: Jeff Negrey, MAemail@example.com|
|Contact: Edward Maytin, MDfirstname.lastname@example.org|