Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial (NCT03769285) | Clinical Trial Compass
UnknownPhase 2
Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial
Canada120 participantsStarted 2018-12-03
Plain-language summary
A common long-term side effect of anti-rejection (immunosuppressant) medications is skin cancer. This pilot clinical trial evaluates the feasibility of conducting a larger pivotal trial to examine the efficacy and safety of nicotinamide for prevention of keratinocyte carcinoma in solid organ transplant recipients. This pilot trial will transition into the pivotal trial if all feasibility targets are met.
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
. Age ≥ 18 years old
. Kidney, liver, heart, or lung transplant at least two years ago
. History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ
. Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus)
. Able to attend follow-up visits
. Able to speak and understand English (only for cognitive substudy)
Exclusion criteria
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
Feasibility (pertaining to patient recruitment)
Timeframe: 1 year
2
Feasibility (pertaining to appropriateness of eligibility criteria)
Timeframe: 1 year
3
Feasibility (pertaining to adherence to intervention)
Timeframe: 1 year
4
Feasibility (pertaining to adherence to follow-up assessments)
Timeframe: 1 year
5
Feasibility (pertaining to data linkage)
Timeframe: 1 year
6
Preliminary pooled keratinocyte carcinoma event rate
. Gorlin syndrome or other genetic skin cancer syndrome
. Solid organ or hematologic malignancy, invasive Stage II melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years, or invasive Stage I melanoma within the past two years