Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
137 participants
OBSERVATIONAL
2017-10-06
2023-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* using topical retinoids, since these can exacerbate the post-PDT erythema reaction
* pregnant
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Edward Maytin, MD, PhD
Physician
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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References
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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.
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.
Other Identifiers
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16-1615
Identifier Type: -
Identifier Source: org_study_id
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