NCT05110924

RCT Treatment Versus Non Treatment of Low-risk BCCs in Elderly

A Large Pragmatic RCT Investigating Treatment Versus Non Treatment of Low-risk BCCs in Elderly

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Basal Cell Carcinoma
• Elderly

Interventions

Type	Name	Description
OTHER	Standard of care	Patients in the treatment arm will receive standard care.
OTHER	Monitoring	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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2021-11-08
• Last updated: 2024-12-17

Locations

1 site across 1 country: Belgium