Biomarker Database Registry for Photodynamic Therapy

Actinic Keratosis Clinical Trial

Official title:

Biomarkers of Clinical Responsiveness to Photodynamic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319251
• Other study ID #: 16-1615
• Status: Completed
• Start date: October 6, 2017
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this research is to obtain a blood sample from patients with actinic keratoses undergoing routine Photodynamic Therapy, in order to measure biomarkers that are relevant to VitD and 5FU metabolism and might be predictive of PDT outcome. The biomarkers to be examined include serum VitD levels at the time of PDT, and the presence/absence of gene alleles that correlate with expression of several proteins involved in VitD and 5FU metabolism. The presence of these biomarkers will be correlated to the improvement in AK lesion counts at the patient's routine follow-up visit 3 months after PDT treatment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actinic Keratosis (AK) clearance	Change in AK lesions present at 3 months post-PDT treatment	at 3 months post-treatment
Primary	Vitamin D levels	Vitamin D level (25-hydroxy-cholecalciferol) measured in serum	At baseline, which is the day of PDT treatment
Secondary	Allele polymorphisms in the gene of the Vitamin D receptor (VDR)	Identify the allele combination present at VDR locus	At baseline, which is the day of PDT treatment
Secondary	Allele polymorphisms in the gene promoter of thymidylate synthase (TS) enzyme	Identify the allele combination present at TS locus	At baseline, which is the day of PDT treatment