Basal Cell CarcinomaJONASNCT02781389
Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions
An observational study of Basal Cell Carcinoma, run by University Hospital, Essen at 1 site in Germany.
Trial summary
The aim of this non-interventional study is to provide further data on the utilization, effectiveness, safety and clinical benefit including duration of response of Vismodegib for treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or radiotherapy under real world clinical conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- How many people
- 53 participants
- Where
- 1 siteGermany
- Study dates
- 29 Apr 2016to 31 May 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 53 Patients with locally advanced BCC who are being treated with Vismodegib will be followed prospectively by centers across Germany and clinical course will be documented
Who may be able to join
- Willing and able to provide informed consent
- Age ≥ 18 years
- laBCC (inappropriate for surgery or radiotherapy)
- Patient is not included in any other trial
- Male or female patient is included in the pregnancy prevention program, as determined by the German authority (BfArM)
Who cannot join
- Patients, for whom treatment with Vismodegib is contraindicated according to the Summary of Product Characteristics (SmPC), which has been in effect at the time of treatment with Vismodegib, including:
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. of the latest SmPC
- Women who are pregnant or breast-feeding
- Women of childbearing potential who do not comply with the Vismodegib (Erivedge) Pregnancy Prevention Programme
- Coadministration of St John's wort (Hypericum perforatum)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie (Universitätsklinikum Essen)
Essen, 45122
About this study
Official title: Non-interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions
The aim of this non-interventional study is to provide further data on the utilization, effectiveness, safety and clinical benefit including duration of response of Vismodegib for treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or radiotherapy under real world clinical conditions.
Read the detailed description
This is a multi-center non-interventional study with 53 patients with locally advanced BCC who start Vismodegib (received at least one dose) in Q4 2015. Duration of recruitment will be one year. Patients will be followed prospectively until disease progression, death, or for 3 years from first dose Vismodegib (whichever occurs first).
The primary effectiveness objective for this study is as follows:
- To evaluate the duration of response defined as duration from first documented response of complete response (CR) or partial response (PR) until disease progression (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment) for laBCC patients.
The secondary effectiveness objectives for this study are as follows:
- Objective response rate (rate of patients with CR or PR) (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment)
- Disease control rate (complete response (CR), partial response (PR) or stable disease (SD))
- Recurrence rate: rate of patients who responded (CR or PR) and later progressed
- Time to progression: time from first treatment to progression
- Time to death: time from first treatment to death
- Time to response: time from first treatment to response
The explorative objectives of this study are to evaluate the following endpoints:
- Type of tumor response evaluation (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment , histological assessment, imaging assessment)
- Treatment decision for therapy with Vismodegib (tumor board OR decision by otorhinolaryngologist, surgeon, plastic surgeon, dermato-oncologist, radiotherapist, ophthalmologist)
- Utilization
- Previous treatment for the BCC lesion, which led to therapy with Vismodegib
- BCC therapy after Vismodegib therapy (if applicable)
- Treatment duration of Vismodegib (start and stop dates for therapy with Vismodegib)
- Assessment of duration and time point of treatment interruptions of Vismodegib
- Reason for treatment discontinuation
- Conditions
- Basal Cell Carcinoma
- Keywords
- Basal cell carcinoma (BCC), advanced BCC (aBCC)
- Medical subject headings
- Carcinoma, Basal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary effectiveness measure: duration of response (partial or complete) until progression, death or up to 3 years from first dose Vismodegib (whichever occurs first)
The primary effectiveness measure for this study is as follows:
- To evaluate the duration of response, defined as duration from first documented complete response (CR) or first documented partial response (PR), whichever cam first, until disease progression (as determined by the treating physician), or death of any reason or up to 3 years from first dose Vismodegib, whichever occurs first, for laBCC patients.
Measured: up to 3 years from first dose Vismodegib
Secondary outcomes (6)
Secondary effectiveness measure: - objective response rate
number of patients with complete response or partial response as determined by the treating physician by clinical assessment, histological assessment, imaging assessment
Measured: up to 3 years from first dose Vismodegib
Secondary effectiveness measure: - time to response
time from first dose Vismodegib to complete response or partial response up to 3 years
Measured: up to 3 years from first dose Vismodegib
Secondary effectiveness measure: - disease control rate
number of complete response, partial response, stable disease
Measured: up to 3 years from first dose Vismodegib
Secondary effectiveness measure: - recurrence rate
number of patients who responded (partial or complete) and later progressed
Measured: up to 3 years from first dose Vismodegib
Secondary effectiveness measure: - time to progression
time from first dose Vismodegib to progression up to 3 years
Measured: up to 3 years from first dose Vismodegib
Secondary effectiveness measure: - survival
time from first dose Vismodegib to death of any cause
Measured: up to 3 years from first dose Vismodegib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study start29 Apr 2016
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- OnkoDataMed GmbH
- Responsible party
- Principal investigator, Prof. Dr. med. Dirk Schadendorf, University Hospital, Essen
- Investigators
- Dirk Schadendorf, Professor, Principal investigator, Universitätsklinikum Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781389
- Sponsor's protocol ID
- ML29828
- Acronym
- JONAS
- Status last verified
- Jun 2021
- First submitted
- 24 Apr 2016
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions
- ClinicalTrials.gov ID
- NCT02781389
- Acronym / sponsor ID
- JONAS / ML29828
- Conditions
- Basal Cell Carcinoma
- Keywords
- Basal cell carcinoma (BCC), advanced BCC (aBCC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- OnkoDataMed GmbH
- Study start
- 29 Apr 2016 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 24 May 2016 (estimated)
- 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.
The aim of this non-interventional study is to provide further data on the utilization, effectiveness, safety and clinical benefit including duration of response of Vismodegib for treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or radiotherapy under real world clinical conditions.
Detailed description
This is a multi-center non-interventional study with 53 patients with locally advanced BCC who start Vismodegib (received at least one dose) in Q4 2015. Duration of recruitment will be one year. Patients will be followed prospectively until disease progression, death, or for 3 years from first dose Vismodegib (whichever occurs first).
The primary effectiveness objective for this study is as follows:
- To evaluate the duration of response defined as duration from first documented response of complete response (CR) or partial response (PR) until disease progression (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment) for laBCC patients.
The secondary effectiveness objectives for this study are as follows:
- Objective response rate (rate of patients with CR or PR) (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment)
- Disease control rate (complete response (CR), partial response (PR) or stable disease (SD))
- Recurrence rate: rate of patients who responded (CR or PR) and later progressed
- Time to progression: time from first treatment to progression
- Time to death: time from first treatment to death
- Time to response: time from first treatment to response
The explorative objectives of this study are to evaluate the following endpoints:
- Type of tumor response evaluation (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment , histological assessment, imaging assessment)
- Treatment decision for therapy with Vismodegib (tumor board OR decision by otorhinolaryngologist, surgeon, plastic surgeon, dermato-oncologist, radiotherapist, ophthalmologist)
- Utilization
- Previous treatment for the BCC lesion, which led to therapy with Vismodegib
- BCC therapy after Vismodegib therapy (if applicable)
- Treatment duration of Vismodegib (start and stop dates for therapy with Vismodegib)
- Assessment of duration and time point of treatment interruptions of Vismodegib
- Reason for treatment discontinuation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 53 Patients with locally advanced BCC who are being treated with Vismodegib will be followed prospectively by centers across Germany and clinical course will be documented
Key inclusion criteria (5 listed)
- Willing and able to provide informed consent
- Age ≥ 18 years
- laBCC (inappropriate for surgery or radiotherapy)
- Patient is not included in any other trial
- Male or female patient is included in the pregnancy prevention program, as determined by the German authority (BfArM)
Key exclusion criteria (5 listed)
- Patients, for whom treatment with Vismodegib is contraindicated according to the Summary of Product Characteristics (SmPC), which has been in effect at the time of treatment with Vismodegib, including:
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. of the latest SmPC
- Women who are pregnant or breast-feeding
- Women of childbearing potential who do not comply with the Vismodegib (Erivedge) Pregnancy Prevention Programme
- Coadministration of St John's wort (Hypericum perforatum)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary effectiveness measure: duration of response (partial or complete) until progression, death or up to 3 years from first dose Vismodegib (whichever occurs first)
Time frame: up to 3 years from first dose Vismodegib
The primary effectiveness measure for this study is as follows: • To evaluate the duration of response, defined as duration from first documented complete response (CR) or first documented partial response (PR), whichever cam first, until disease progression (as determined by the treating physician), or death of any reason or up to 3 years from first dose Vismodegib, whichever occurs first, for laBCC patients.
6 secondary outcomes
Secondary effectiveness measure: - objective response rate
Time frame: up to 3 years from first dose Vismodegib
Secondary effectiveness measure: - time to response
Time frame: up to 3 years from first dose Vismodegib
Secondary effectiveness measure: - disease control rate
Time frame: up to 3 years from first dose Vismodegib
Secondary effectiveness measure: - recurrence rate
Time frame: up to 3 years from first dose Vismodegib
Secondary effectiveness measure: - time to progression
Time frame: up to 3 years from first dose Vismodegib
Secondary effectiveness measure: - survival
Time frame: up to 3 years from first dose Vismodegib
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- 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.
Dirk Schadendorf, Professor principal investigator
Universitätsklinikum Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by University Hospital, Essen at 1 site in Germany.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 3 Jun 2021. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary effectiveness measure: duration of response (partial or complete) until progression, death or up to 3 years from first dose Vismodegib (whichever occurs first) (time frame: up to 3 years from first dose Vismodegib). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2021.