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Vitamin D Effects on Immune Microenvironment of Nonmelanoma Skin Cancer After Photodynamic Therapy (PDT)

RecruitingNAAges 18 Years - anyAllCase Comprehensive Cancer Center
NCT07241585 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This research study is for people who have been diagnosed with a nonmelanoma skin cancer (either basal cell carcinoma or squamous cell carcinoma) and are planning to receive either Mohs surgery or ED\&C (electrodessication \& curettage) as part of clinical care. The purpose of this study is to understand how photodynamic therapy (PDT) with or without Vitamin D can promote an immune response to skin cancer. For this study, participants will be randomized (randomly assigned) and asked to take Vitamin D or placebo for 6 days and come to the clinic for a single PDT treatment 1-14 days prior to their surgery. At this visit, photographs of participant's skin cancer will be taken, and participants will undergo PDT treatment. The study team will also take photos on the day of Mohs surgery or ED\&C. There will be up to two blood draws for research. If participants do not want to come in for a P

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📋 Eligibility rules (as published)
Inclusion Criteria: * Must be an adult participant (\> 18 yrs) who is scheduled to undergo Mohs surgery or ED\&C within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic. * Must have at least one BCC or SCC tumor eligible for removal by Mohs surgery. * The original tumor size prior to biopsy must be \>1.0 cm (in the longest diameter). * Participants of any ethnic group are eligible for this trial. * Must provide informed consent to participate in the trial. * Participant must live in Ohio (Groups 2 \& 3), because Research Pharmacy cannot ship the study drugs outside of the state. Exclusion Criteria: * Pregnant or breastfeeding * Currently being treated for other cancers with medical or radiation therapy * Known hypersensitivity to 5-aminolevulinic acid * History of a photosensitivity disease, e.g., porphyria cutanea tarda
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What it tests

  • Vitamin D (VitD)
  • Placebo
  • Photodynamic therapy (PDT)
  • Mohs surgery or electrodessication & curettage (ED&C) (standard of care)
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Where

1 site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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