Basal Cell Carcinoma, Elderly
Conditions
Keywords
Watchful waiting, Active surveillance
Brief summary
This study will be a randomized controlled trial (RCT). Patients with a minimum age of 75 years who consult at the dermatology department of the Ghent University Hospital and who are diagnosed with minimum one lesion suspicious for a low-risk basal cell carcinoma will be asked to participate in this study. Rationale: Basal cell carcinomas (BCCs) represent 70% of all skin cancers. These tumors do not metastasize but are locally invasive if left untreated. There is a high incidence of BCC in elderly and clinicians frequently face important treatment dilemmas. The approach to BCC in elderly should be investigated thoroughly, since current data on health-related quality of life, complication risks and biological behavior of these tumors is absent, and most guidelines are based on studies in young patients. Objective: The investigators will examine the possibility of not treating all BCCs by collecting data on the in vivo biological behavior of low-risk basal cell carcinomas in elderly patients with state-of-the-art imaging techniques. The investigators want to combine tumor characteristics with patient profiles, in order to estimate whether a chosen treatment will positively affect the patients' quality of life within a predetermined timeframe. Study design: Randomized controlled trial (RCT) with study visits every 6 to 12 months for a total follow-up period of 36 months. Study population: Patients consulting at the Department of Dermatology of the Ghent University Hospital with the minimum age of 75 years and a new diagnosis of (a) low-risk basal cell carcinoma(s). Intervention: Evaluation of the impact on the quality of life and the complication risks in both study arms. In addition, survival data will be gathered in both study arms. In the non-treatment arm, there will be an evaluation of the biological behavior of these low-risk basal cell carcinomas using in vivo imaging devices. Patients in the treatment arm will receive standard care. Patients in the non-treatment arm will be closely monitored: the tumor will be evaluated using non-invasive imaging devices. Patients will be asked to fill in a questionnaire concerning their HrQoL at consecutive time points. Also patient-reported side effects will be evaluated via a questionnaire. The investigators will compare standard treatment versus non-treatment (1:1 allocation) in a randomized controlled trial. Subjects can withdraw from participating in this study at any time for any reason without any consequences.
Detailed description
See protocol
Interventions
OTHERStandard of care
Patients in the treatment arm will receive standard care.
OTHERMonitoring
Patients in the non-treatment arm will be closely monitored: the tumor will be evaluated using non-invasive imaging devices based on multispectral dermoscopy, reflectance confocal microscopy to determine the exact histology and high definition optical coherence tomography for imaging and volume calculation of the BCC.
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
The patient will go through the stratification and randomization process and will be randomly allocated to either the treatment or the non-treatment arm of the study. The treatment (i.e. surgery, topical treatment or CO2-laser) will be performed by an independent dermatologist of the investigator's department who is blinded and is not aware of the patient's participation in this study.
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients with the age of 75 years or older with a new diagnosis of at least one basal cell carcinoma localized on the trunk or on the limbs (with the exception of BCCs on the hands and/or the feet).
Exclusion criteria
* Patient is unable to provide consent. * Patient is unable to understand the task and questionnaires. * Patient is immunocompromised. * Patient has a genetic skin cancer syndrome. * The BCC has a diameter of more than 3 cm. * The BCC occurs in a skin site that underwent radiotherapy in the past. * Patient is being treated with chemoprevention for KC or underwent a recent field treatment for KC in the region of the low-risk BCC. * Patient has a history of malignant melanoma or other types of NMSC (with the exception of KC). * Patient has had a high-risk SCC during the last 2 years or a SCC in the head and neck region during the last 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life | Day 0 | To determine the impact on the health-related quality of life in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm. |
| Complication risks | Day of Treatment | To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Month 36 + 10 years | To determine the survival of elderly patients with low-risk basal cell carcinoma in the treatment versus the non-treatment arm. |
| Natural behavior | Day 0 | To evaluate the in vivo natural behavior and growth of the basal cell carcinomas in the non-treatment arm. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment effectiveness | Month 36 | To determine treatment effectiveness (recurrence rates of the BCCs after 36 months) of the different (standard of care) therapies administered in the treatment arm. |
Countries
Belgium
Outcome results
None listed