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Trial Title:
Real-world Evaluation of Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma
NCT ID:
NCT06252857
Condition:
Basal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Basal Cell
Imiquimod
Conditions: Keywords:
imiquimod
surgical excision
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Imiquimod Topical
Description:
Topical application of imiquimod (once daily, 5 days a week, during 6 weeks) versus
surgical excision.
Other name:
Surgical Excision
Summary:
Basal cell carcinoma (BCC) is the most prevalent form of cancer among the Caucasian
population. There are several subtypes of BCC with different clinical characteristics and
treatment strategies. Superficial and nodular BCCs are low-risk BCC subtypes. The
diagnosis and subtype of BCC can be confirmed by means of punch biopsy, but non-invasive
diagnosis by means of Optical Coherence Tomography (OCT) is proven to be a non-inferior
alternative diagnostic instrument. Besides, non-invasive topical treatment is recommended
as valuable treatment alternative to surgical excision for low-risk BCC.
Since non-invasive diagnosis and treatment for low-risk BCC is being implemented into
daily practice, we want to evaluate the real-world effectiveness of different invasive
and non-invasive diagnostic and treatment strategies in the management of low-risk BCC.
This real-world evidence will enhance our understanding of these management strategies
for low-risk BCC in daily practice.
Criteria for eligibility:
Study pop:
Patients visiting the outpatient department of MUMC+ with a clinical suspicion for
low-risk BCC, who have a final diagnosis of low-risk BCC confirmed by OCT, or by punch
biopsy in case uncertainty about diagnosis remains after OCT. Patients will be treated in
accordance with standard care: either SE or IMQ. The choice for treatment is based on
shared decision making.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients ≥18 years old
- Diagnosis of low-risk BCC based on CDE with OCT confirmation or with
histopathological verification in case OCT diagnosis is doubtful.
- Tumors meeting the criteria for low-risk BCC
- Patient is able to understand the instruction regarding the study participation and
application of IMQ treatment
Exclusion Criteria:
- Tumor location in the H-zone of the face or hairy scalp, anogenital area
- Diagnosis of recurrent BCC or previous skin cancer within 2cm of the treatment area
- Strong suspicion/diagnosis of high-risk BCC subtype or other skin condition on OCT
or punch biopsy
- Women who are pregnant or breastfeeding
- Previous allergy or intolerance to IMQ
- No concurrent use any other systemic chemopreventive or immunosuppressive medication
during the treatment period, 30 days before start and 3 months after the end of
treatment
- Limited understanding of the Dutch language and not being able to give informed
consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Maastricht UMC+
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Myrthe MG Moermans, MD
Phone:
+31433877295
Email:
myrthe.moermans@mumc.nl
Investigator:
Last name:
Klara Mosterd, Prof.
Email:
Principal Investigator
Investigator:
Last name:
Myrthe Moermans, MD
Email:
Sub-Investigator
Start date:
April 22, 2024
Completion date:
April 2026
Lead sponsor:
Agency:
Maastricht University Medical Center
Agency class:
Other
Source:
Maastricht University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06252857
