Clinical trial NCT03319251: Biomarker Database Registry for Photodynamic Therapy
Official title: Biomarkers of Clinical Responsiveness to Photodynamic Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratosis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The desired population for this study is 100 patients who have at least 10 nonhypertrophic actinic keratosis lesions present on the face, scalp, forearms, chest, or legs and are scheduled to receive Photodynamic Therapy (PDT) at the Cleveland Clinic noninvasive cutaneous oncology clinic.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Actinic Keratosis (AK) clearance
timeFrame: at 3 months post-treatment
measure: Vitamin D levels
timeFrame: At baseline, which is the day of PDT treatment
Secondary outcomes:
measure: Allele polymorphisms in the gene of the Vitamin D receptor (VDR)
timeFrame: At baseline, which is the day of PDT treatment
measure: Allele polymorphisms in the gene promoter of thymidylate synthase (TS) enzyme
timeFrame: At baseline, which is the day of PDT treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
citation: 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.
citation: 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.