Clinical trial NCT05110924: RCT Treatment Versus Non Treatment of Low-risk BCCs in Elderly
Official title: A Large Pragmatic RCT Investigating Treatment Versus Non Treatment of Low-risk BCCs in Elderly
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Basal Cell Carcinoma
Elderly
Keywords: Watchful waiting
Active surveillance
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 9
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Health-related Quality of Life
timeFrame: Day 0
measure: Health-related Quality of Life
timeFrame: Day of Treatment
measure: Health-related Quality of Life
timeFrame: Month 6
measure: Health-related Quality of Life
timeFrame: Month 12
measure: Health-related Quality of Life
timeFrame: Month 24
measure: Health-related Quality of Life
timeFrame: Month 36
measure: Complication risks
timeFrame: Day of Treatment
measure: Complication risks
timeFrame: Month 6
measure: Complication risks
timeFrame: Month 12
measure: Complication risks
timeFrame: Month 24
measure: Complication risks
timeFrame: Month 36
Secondary outcomes:
measure: Survival
timeFrame: Month 36 + 10 years
measure: Natural behavior
timeFrame: Day 0
measure: Natural behavior
timeFrame: Month 6
measure: Natural behavior
timeFrame: Month 12
measure: Natural behavior
timeFrame: Month 24
measure: Natural behavior
timeFrame: Month 36
Other outcomes:
measure: Treatment effectiveness
timeFrame: Month 36
Locations:
city: Ghent
country: Belgium
facility: Department of Dermatology, Ghent University Hospital
state: East Flanders
Study officials:
affiliation: Ghent University Hospital, Department of Dermatology
name: Lieve Brochez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Coile L, Verhaeghe E, Ongenae K, Brochez L, Hoorens I. Study protocol of the BASINEL Study: a pragmatic randomised controlled trial investigating treatment versus no treatment of low-risk basal cell carcinomas in older persons. BMJ Open. 2022 Nov 10;12(11):e063526. doi: 10.1136/bmjopen-2022-063526.