Squamous Cell Skin Carcinoma Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 PDT treatment prior to their Mohs surgery or ED\&C, they will have the option to participate by only allowing the study team to collect data about their skin cancer and their tissue from Mohs surgery or ED\&C.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
RECRUITING
Cleveland
Contact Information
Primary
Edward Maytin, MD, PhD
maytine@ccf.org
(216) 346-6022
Time Frame
Start Date: 2026-02-25
Estimated Completion Date: 2027-08
Participants
Target number of participants: 54
Treatments
Other: Arm 1: Participants donate discarded tissue for research (No VitD/Placebo + no PDT)
Participants in Arm 1 will donate discarded tissue from their scheduled standard of care Mohs surgery or ED\&C. They will not be randomized to receive VitD or placebo and will not have PDT.
Experimental: Arm 2: VitD + PDT prior to Mohs surgery or ED&C
Participants in Arms 2 and 3 will be randomized to receive either VitD or placebo prior to PDT and Mohs surgery or ED\&C visit.
Placebo_comparator: Arm 3: Placebo + PDT prior to Mohs surgery or ED&C
Participants in Arms 2 and 3 will be randomized to receive either VitD or placebo prior to PDT and Mohs surgery or ED\&C visit.
Sponsors
Leads: Case Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov