Basal Cell CarcinomaREDT-BCCNCT06252857
Real-world Evaluation of Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma
An observational study of Basal Cell Carcinoma, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Imiquimod Topical
- How many people
- 142 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Apr 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Evaluation of (Non-invasive) Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma: a Prospective Cohort Study
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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Imiquimod Topical
- Keywords
- imiquimod, surgical excision
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod TopicalDrug
Also called Surgical Excision
Topical application of imiquimod (once daily, 5 days a week, during 6 weeks) versus surgical excision.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of imiquimod versus surgical excision
Treatment success, expressed as the proportion of tumor free patients
Measured: 1 year post-treatment
Secondary outcomes (5)
Adverse effects
Incidence and severity of adverse effects
Measured: During imiquimod treatment, reported by the patient
Mean treatment compliance for patients in the imiquimod group
In percentages
Measured: During treatment, reported by the patient in a treatment checklist
Cosmetic outcome
Patient-reported satisfaction with cosmetic result of treatment area, expressed as mean score on the DASS questionnaire
Measured: 1 year post-treatment
Patient treatment satisfaction
Patient-reported satisfaction with treatment, expressed as the proportion of patients reporting to be satisfied with their treatment on a 4-point Likert-scale.
Measured: 1 year post-treatment
Cost-effectiveness analysis
Cost-effectiveness will be analysed from a health-care perspective: pre-, during and post-treatment costs will be recorded and analysed and compared in both treatment groups using a cost-effectiveness analysis (CEA)
Measured: 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start22 Apr 2024
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252857
- Sponsor's protocol ID
- 2023-0356
- Acronym
- REDT-BCC
- Status last verified
- Oct 2026
- First submitted
- 18 Jan 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Undecided: IPD may be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of (Non-invasive) Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06252857
- Acronym / sponsor ID
- REDT-BCC / 2023-0356
- Conditions
- Basal Cell Carcinoma
- Keywords
- imiquimod, surgical excision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imiquimod TopicalAlso: Surgical ExcisionTopical application of imiquimod (once daily, 5 days a week, during 6 weeks) versus surgical excision. | Drug | – |
Primary outcome
Effectiveness of imiquimod versus surgical excision
Time frame: 1 year post-treatment
Treatment success, expressed as the proportion of tumor free patients
5 secondary outcomes
Adverse effects
Time frame: During imiquimod treatment, reported by the patient
Mean treatment compliance for patients in the imiquimod group
Time frame: During treatment, reported by the patient in a treatment checklist
Cosmetic outcome
Time frame: 1 year post-treatment
Patient treatment satisfaction
Time frame: 1 year post-treatment
Cost-effectiveness analysis
Time frame: 1 year post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided. IPD may be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of imiquimod versus surgical excision (time frame: 1 year post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.