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

Elderly Clinical Trial

— BASINEL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05110924
• Other study ID #: BASINEL
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 31, 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: Laura Van Coile, MD
• Phone: +3293322287
• Email: laura.vancoile[@]uzgent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See protocol

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma, Basal Cell
• Elderly

Intervention

Other:
• Standard of care
Patients in the treatment arm will receive standard care.
• 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.

Locations

Country	Name	City	State
Belgium	Department of Dermatology, Ghent University Hospital	Ghent	East Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment effectiveness	To determine treatment effectiveness (recurrence rates of the BCCs after 36 months) of the different (standard of care) therapies administered in the treatment arm.	Month 36
Primary	Health-related Quality of Life	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.	Day 0
Primary	Health-related Quality of Life	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.	Day of Treatment
Primary	Health-related Quality of Life	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.	Month 6
Primary	Health-related Quality of Life	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.	Month 12
Primary	Health-related Quality of Life	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.	Month 24
Primary	Health-related Quality of Life	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.	Month 36
Primary	Complication risks	To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.	Day of Treatment
Primary	Complication risks	To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.	Month 6
Primary	Complication risks	To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.	Month 12
Primary	Complication risks	To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.	Month 24
Primary	Complication risks	To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.	Month 36
Secondary	Survival	To determine the survival of elderly patients with low-risk basal cell carcinoma in the treatment versus the non-treatment arm.	Month 36 + 10 years
Secondary	Natural behavior	To evaluate the in vivo natural behavior and growth of the basal cell carcinomas in the non-treatment arm.	Day 0
Secondary	Natural behavior	To evaluate the in vivo natural behavior and growth of the basal cell carcinomas in the non-treatment arm.	Month 6
Secondary	Natural behavior	To evaluate the in vivo natural behavior and growth of the basal cell carcinomas in the non-treatment arm.	Month 12
Secondary	Natural behavior	To evaluate the in vivo natural behavior and growth of the basal cell carcinomas in the non-treatment arm.	Month 24
Secondary	Natural behavior	To evaluate the in vivo natural behavior and growth of the basal cell carcinomas in the non-treatment arm.	Month 36