Basal Cell CarcinomaPhase 3NCT05046262
Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study
A Phase 3 study testing Calcium chloride in people with Basal Cell Carcinoma, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Calcium chloride
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Jan 2020to 22 Feb 2022
- Phase
- Phase 3
- 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
Who may be able to join
- Primary low risk basal cell carcinoma less than 3 cm in diameter
- -
Who cannot join
- Immunosuppression or organ transplant recipients Pregnancy or breastfeeding Allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Dermatology, Bispebjerg Hospital
Copenhagen, 2400
Stine Wiegell, MD PhD, +4530914617, stine.regin.wiegell@regionh.dk
About this study
25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation
Read the detailed description
25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation, if partial or no response after 3 months the treatment was repeated. Follow-up 3 and 12 months after last treatment.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Calcium chloride
- 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.
Calcium chlorideDrug
Also called electroporation
Calcium electroporation
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start8 Jan 2020
- Primary completion22 Feb 2022 (estimated)
- Study completion22 Feb 2022 (estimated)
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mirai Medical, Ireland
- Responsible party
- Principal investigator, Stine Wiegell, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046262
- Sponsor's protocol ID
- EudraCT 2019-002730-36
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study
- ClinicalTrials.gov ID
- NCT05046262
- Acronym / sponsor ID
- EudraCT 2019-002730-36
- Conditions
- Basal Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Mirai Medical, Ireland
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 22 Feb 2022 (estimated)
- Study completion
- 22 Feb 2022 (estimated)
- First posted
- 16 Sep 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.
25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation
Detailed description
25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation, if partial or no response after 3 months the treatment was repeated. Follow-up 3 and 12 months after last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary low risk basal cell carcinoma less than 3 cm in diameter
- -
Key exclusion criteria (1 listed)
- Immunosuppression or organ transplant recipients Pregnancy or breastfeeding Allergy to local anesthetics
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 |
|---|---|---|
| Calcium chlorideAlso: electroporationCalcium electroporation | Drug | – |
Primary outcome
complete response
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Department of Dermatology, Bispebjerg Hospital
Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcium chloride in people with Basal Cell Carcinoma, run by Bispebjerg Hospital at 1 site in Denmark.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Sep 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 Denmark. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (time frame: 3 months). 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 16 Sep 2021.