Basal Cell CarcinomaBASINELNCT05110924
RCT Treatment Versus Non Treatment of Low-risk BCCs in Elderly
A study testing Monitoring in people with Basal Cell Carcinoma and Elderly, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Elderly
- What is being tested?
- Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2021to 1 Jun 2024
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Dermatology, Ghent University Hospital
Ghent, East Flanders, 9000
About this study
Official title: A Large Pragmatic RCT Investigating Treatment Versus Non Treatment of Low-risk BCCs in Elderly
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.
Read more
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.
Read the detailed description
See protocol
- Conditions
- Basal Cell Carcinoma, Elderly
- Being tested
- Standard of care, Monitoring
- Keywords
- Watchful waiting, Active surveillance
- 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.
Standard of careOther
Patients in the treatment arm will receive standard care.
MonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm (T-arm) | Other | Patients in the T-arm will receive diagnostic investigation(s) as in standard care. This includes clinical and dermoscopic examination and (in most cases) a biopsy to confirm the diagnosis of a BCC. Patients will be asked to fill out a questionnaire (Q) concerning their HrQoL. Important is the possible exclusion of patients (when the biopsy shows the lesion is not a BCC) in this step.
Patients will receive treatment of their BCC in accordance with the standard treatment regimen. The treatment will be performed by an independent dermatologist of the investigator's department who is blinded and not aware of the patient's participation in this study. After the treatment, a new Q will be sent out to capture the HrQoL and possible patient-reported side effects. Afterwards, the patients will be followed every 6 to 12 months for 36 months with a clinical evaluation of the previously treated skin site, evaluation of possible complications and the HrQoL and complications Qs. Receives: Other: Standard of care |
| non-Treatment arm (n-T-arm) | Other | Patients allocated to the n-T-arm will receive diagnostic investigations by non-invasive imaging techniques to confirm the diagnosis of a BCC. Patients will be asked to fill out a Q concerning their HrQoL. Important to point out is the possible exclusion of certain patients (when the imaging shows the lesion is not a BCC) in this step.
The patients in this arm will be followed every 6 to 12 months for 36 months. Every study visit there will be a clinical evaluation of the tumor. At the follow-up visits of 6, 12, 24 and 36 months a new documentation of the tumor will take place with in vivo imaging. At these time-points, patients will also be asked to fill out the HrQoL Q and complications Q.
Because of ethical reasons, a maximum tolerable diameter of the tumor has been defined in advance: BCCs in the non-treatment arm that reach a diameter of 4cm will be excluded and will receive treatment. Receives: Other: Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
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.
Measured: Day of Treatment
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.
Measured: Month 6
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.
Measured: Month 12
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.
Measured: Month 24
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.
Measured: Month 36
Complication risks
To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.
Measured: Day of Treatment
Complication risks
To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.
Measured: Month 6
Complication risks
To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.
Measured: Month 12
Complication risks
To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.
Measured: Month 24
Complication risks
To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.
Measured: Month 36
Secondary outcomes (6)
Survival
To determine the survival of elderly patients with low-risk basal cell carcinoma in the treatment versus the non-treatment arm.
Measured: Month 36 + 10 years
Natural behavior
To evaluate the in vivo natural behavior and growth of the basal cell carcinomas in the non-treatment arm.
Measured: Day 0
Natural behavior
To evaluate the in vivo natural behavior and growth of the basal cell carcinomas in the non-treatment arm.
Measured: Month 6
Natural behavior
To evaluate the in vivo natural behavior and growth of the basal cell carcinomas in the non-treatment arm.
Measured: Month 12
Natural behavior
To evaluate the in vivo natural behavior and growth of the basal cell carcinomas in the non-treatment arm.
Measured: Month 24
Natural behavior
To evaluate the in vivo natural behavior and growth of the basal cell carcinomas in the non-treatment arm.
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lieve Brochez, MD, PhD, Principal investigator, Ghent University Hospital, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110924
- Sponsor's protocol ID
- BASINEL
- Acronym
- BASINEL
- Status last verified
- Dec 2024
- First submitted
- 14 Oct 2021
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36356999
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large Pragmatic RCT Investigating Treatment Versus Non Treatment of Low-risk BCCs in Elderly
- ClinicalTrials.gov ID
- NCT05110924
- Acronym / sponsor ID
- BASINEL / BASINEL
- Conditions
- Basal Cell Carcinoma, Elderly
- Keywords
- Watchful waiting, Active surveillance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 8 Nov 2021 (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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm (T-arm) | Other | Other: Standard of carePatients in the T-arm will receive diagnostic investigation(s) as in standard care. This includes clinical and dermoscopic examination and (in most cases) a biopsy to confirm the diagnosis of a BCC. Patients will be asked to fill out a questionnaire (Q) concerning their HrQoL. Important is the possible exclusion of patients (when the biopsy shows the lesion is not a BCC) in this step. Patients will receive treatment of their BCC in accordance with the standard treatment regimen. The treatment will be performed by an independent dermatologist of the investigator's department who is blinded and not aware of the patient's participation in this study. After the treatment, a new Q will be sent out to capture the HrQoL and possible patient-reported side effects. Afterwards, the patients will be followed every 6 to 12 months for 36 months with a clinical evaluation of the previously treated skin site, evaluation of possible complications and the HrQoL and complications Qs. |
| non-Treatment arm (n-T-arm) | Other | Other: MonitoringPatients allocated to the n-T-arm will receive diagnostic investigations by non-invasive imaging techniques to confirm the diagnosis of a BCC. Patients will be asked to fill out a Q concerning their HrQoL. Important to point out is the possible exclusion of certain patients (when the imaging shows the lesion is not a BCC) in this step. The patients in this arm will be followed every 6 to 12 months for 36 months. Every study visit there will be a clinical evaluation of the tumor. At the follow-up visits of 6, 12, 24 and 36 months a new documentation of the tumor will take place with in vivo imaging. At these time-points, patients will also be asked to fill out the HrQoL Q and complications Q. Because of ethical reasons, a maximum tolerable diameter of the tumor has been defined in advance: BCCs in the non-treatment arm that reach a diameter of 4cm will be excluded and will receive treatment. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Standard of carePatients in the treatment arm will receive standard care. | Other | Treatment arm (T-arm) |
| MonitoringPatients 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. | Other | non-Treatment arm (n-T-arm) |
Primary outcome
Health-related Quality of Life
Time frame: 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.
Health-related Quality of Life
Time frame: Day of Treatment
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.
Health-related Quality of Life
Time frame: Month 6
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.
Health-related Quality of Life
Time frame: Month 12
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.
Health-related Quality of Life
Time frame: Month 24
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.
Health-related Quality of Life
Time frame: Month 36
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
Time frame: 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.
Complication risks
Time frame: Month 6
To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.
Complication risks
Time frame: Month 12
To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.
Complication risks
Time frame: Month 24
To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.
Complication risks
Time frame: Month 36
To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.
6 secondary outcomes
Survival
Time frame: Month 36 + 10 years
Natural behavior
Time frame: Day 0
Natural behavior
Time frame: Month 6
Natural behavior
Time frame: Month 12
Natural behavior
Time frame: Month 24
Natural behavior
Time frame: Month 36
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 36356999Van 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.
- Individual participant dataSharing planned: No
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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.
Lieve Brochez, MD, PhD principal investigator
Ghent University Hospital, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring in people with Basal Cell Carcinoma and Elderly, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Dec 2024. 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 Belgium. 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 was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
Health-related Quality of Life (time frame: Day 0). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05110924, which also lists 1 linked publication.
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 17 Dec 2024.