Alteration of the Immune Microenvironment in Basal Cell Carcinoma Following Photodynamic Therapy (NCT05020912) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Alteration of the Immune Microenvironment in Basal Cell Carcinoma Following Photodynamic Therapy
United States18 participantsStarted 2021-12-13
Plain-language summary
The purpose of this study is to better understand the immune response to basal cell carcinoma (BCC) treated with Photodynamic Therapy (PDT) in order to develop new methods of treating BCC. Previous research suggests that PDT alters the immune response, possibly in a way that could promote better tumor clearance when combined with other treatments. Overall, participation in this study will help the study team better understand the anti-tumor immune response when BCC is treated with PDT.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Must be an adult parcticpant (\> 18 yrs) who is scheduled to undergo BCC surgery (via Mohs surgery, ED\&C, or standard elliptical excision) within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic.
* Must have at least one BCC tumor eligible for surgical removal
* Participants of any ethnic group are eligible for this trial.
* Must provide informed consent to participate in the trial.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to maximum expression of immune checkpoint molecules
Timeframe: at visit 2 (1-14 days)
2
Altered expression of immune checkpoint molecules
Timeframe: at visit 2 (1-14 days)
3
Altered recruitment of different immune cell subtypes in BCC tumor specimens