Status:
NOT_YET_RECRUITING
Basal Cell Carcinoma Chemoprevention Trial
Lead Sponsor:
VA Office of Research and Development
Conditions:
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an intent-to-treat, parallel design, multicenter randomized trial and the primary intervention is a double-blind comparison of Imiquimod (IMQ) vs. placebo cream for preventing basal cell carci...
Detailed Description
Basal Cell Carcinoma (BCC) is the most common cancer in the United States. It afflicts 2 to 3 million Americans each year, more than all non-skin cancers combined. Notably, US active duty military and...
Eligibility Criteria
Inclusion
- Veteran age 18 years or older
- 2 (or more) qualifying BCC lesions in the prior 5 years, with at least one located on the face, neck, ears, or scalp. "Qualifying lesions are those that meet the two inclusion criterion bullet points below, and none of the exclusion criteria listed in "B".
- Qualifying lesions not in a field of prior radiation therapy.
- Qualifying lesions not a recurrence after treatment, but the original lesion can qualify whether it recurred or not.
Exclusion
- AK or KC field therapy on the face (5-FU cream, IMQ, diclofenac gel, chemical peel, or photodynamic therapy) for BCC treatment on the face in the last 2 months because it can cause inflammation that may interfere with the IMQ treatment. After 2 months, these patients can be included.
- IMQ therapy on the face in the past year, although such therapy in the more distant past is not an exclusion.
- Suspicious skin lesions suggestive of any type of skin cancer present on the face at the initial exam conducted for the study must be removed and have another skin exam to confirm the facial skin cancer is cleared for 1 month prior to randomization so that the investigators can be confident that skin cancer lesions that arise during the trial are new.
- Currently receiving or received in the past two months: immune checkpoint inhibitor, hedgehog pathway inhibitor, or oral capecitabine.
- History of cutaneous T-cell lymphoma within the past year, but low-grade prostate cancer, patch stage CTCL, breast cancer, and history of solid hematologic cancer deemed to be in remission will be included.
- Genetic disorder associated with very high basal cell skin cancer risk (i.e., basal cell nevus syndrome, xeroderma pigmentosum) because prevention efforts with IMQ may have dramatically different efficacy in these patients compared to the general high-risk population.
- Solid organ or bone marrow transplant recipient such as renal, hepatic, or cardiac transplant because these patients are at increased risk of KC (much greater risk of SCC than BCC) and the associated immunodeficiency may affect the effectiveness of IMQ
- Radiation therapy to the face
- Known allergy to IMQ or cream vehicle
- Woman currently pregnant or breast feeding
- Woman of childbearing potential unwilling to use birth control
- Judged by investigator to have a very high mortality risk within a year due to co-morbid illness
- Judged by investigator to be unlikely to comply with protocol requirements
- Judged by investigator not to be competent to provide informed consent
- Unable to communicate in English
- Enrolled in another therapeutic interventional trial
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
1630 Patients enrolled
Trial Details
Trial ID
NCT05212246
Start Date
January 1 2026
End Date
January 1 2032
Last Update
June 5 2025
Active Locations (1)
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1
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908-4734