Malignant MelanomaNCT01077050
SciBase International Melanoma Pivotal Study
A study testing SciBase III Electrical Impedance Spectrometer in people with Malignant Melanoma, run by SciBase AB at 2 sites in 2 countries.
Trial summary
The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- SciBase III Electrical Impedance Spectrometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,951 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For inclusion in the study, all subjects had to fulfill all of the following criteria:
- Men or women of any ethnic group aged ≥18 years
- Primary lesions (i.e., not metastases or recurrent lesions) that the physicians choose to excise.
- Lesion ≥ 2 mm in diameter and ≤ 20 mm in diameter
- In subjects with multiple skin lesions, all lesions destined for excision must be identified for purposes of study participation. Note: a subject may only be entered into the study once.
- The subject is willing and able to read, understand and sign the study specific informed consent form.
Who cannot join
- Subjects were excluded from the study if they fulfilled any of the following criteria:
- Skin surface not measurable, e.g. lesion on a stalk
- Skin surface not accessible, e.g. inside ears, under nails
- Lesion located on acral skin, e.g. sole or palms.
- Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions.
- Lesion on hair-covered areas, e.g. scalp, beards, moustaches or whiskers.
Show all 12Show fewer
- Lesion located on genitalia.
- Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized.
- Lesion located on mucosal surfaces.
- Skin is not intact (measurement area) e.g. bleeding or with clinical noticeable ulceration.
- Lesion with foreign matter, e.g. tattoo, splinter
- Lesion and/or reference located on acute sunburn.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference).
The purpose of the study is to collect data to support a Pre-market Application(PMA) to obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical Impedance Spectrometer.
- Conditions
- Malignant Melanoma
- Being tested
- SciBase III Electrical Impedance Spectrometer
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SciBase III Electrical Impedance SpectrometerDevice
SciBase III Electrical Impedance Spectrometer is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Enrolled subject will undergo skin measurements with SciBase III Electrical Impedance Spectrometer. The relevant skin lesion(s) will be excised and diagnosed as per routine treatment.
| Study group | Role | What they receive |
|---|---|---|
| SciBase III | Other | Subjects with suspected malignant melanoma or lesions designated for total excision were included into the study. To ensure no selection bias, all eligible lesions from a subject were included into the study. All study eligible skin lesion(s) were examined with the investigational device, photographed and removed by an excisional biopsy. Receives: Device: SciBase III Electrical Impedance Spectrometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
SciBase Sensitivity and Specificity
This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device:
- Sensitivity ≥ 0.90 to detect Melanoma
- Sensitivity - (1-Specificity) > 0.00
Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma.
Measured: Post data lock
Secondary outcomes (1)
Sensitivity and Specificity
Secondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis.
Positive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia)
Negative Reference Diagnosis: All other skin lesions.
Measured: Post data lock
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,951 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciBase AB
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrik H Birgersson, PhD, Study director, SciBase and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077050
- Sponsor's protocol ID
- SIMPS
- Status last verified
- Nov 2013
- First submitted
- 25 Feb 2010
- Last updated
- 30 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Aberg P, Nicander I, Holmgren U, Geladi P, Ollmar S. Assessment of skin lesions and skin cancer using simple electrical impedance indices. Skin Res Technol. 2003 Aug;9(3):257-61. doi: 10.1034/j.1600-0846.2003.00017.x.
PubMed 12877688Aberg P, Nicander I, Hansson J, Geladi P, Holmgren U, Ollmar S. Skin cancer identification using multifrequency electrical impedance--a potential screening tool. IEEE Trans Biomed Eng. 2004 Dec;51(12):2097-102. doi: 10.1109/TBME.2004.836523.
PubMed 15605856
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SciBase International Melanoma Pivotal Study
- ClinicalTrials.gov ID
- NCT01077050
- Acronym / sponsor ID
- SIMPS
- Conditions
- Malignant Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,951 participants (actual)
- Lead sponsor
- SciBase ABUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Posted 30 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference).
The purpose of the study is to collect data to support a Pre-market Application(PMA) to obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical Impedance Spectrometer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SciBase III | Other | Device: SciBase III Electrical Impedance SpectrometerSubjects with suspected malignant melanoma or lesions designated for total excision were included into the study. To ensure no selection bias, all eligible lesions from a subject were included into the study. All study eligible skin lesion(s) were examined with the investigational device, photographed and removed by an excisional biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women of any ethnic group aged ≥18 years
- Primary lesions (i.e., not metastases or recurrent lesions) that the physicians choose to excise.
- Lesion ≥ 2 mm in diameter and ≤ 20 mm in diameter
- In subjects with multiple skin lesions, all lesions destined for excision must be identified for purposes of study participation. Note: a subject may only be entered into the study once.
- The subject is willing and able to read, understand and sign the study specific informed consent form.
Key exclusion criteria (12 listed)
- Skin surface not measurable, e.g. lesion on a stalk
- Skin surface not accessible, e.g. inside ears, under nails
- Lesion located on acral skin, e.g. sole or palms.
- Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions.
- Lesion on hair-covered areas, e.g. scalp, beards, moustaches or whiskers.
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 |
|---|---|---|
| SciBase III Electrical Impedance SpectrometerSciBase III Electrical Impedance Spectrometer is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Enrolled subject will undergo skin measurements with SciBase III Electrical Impedance Spectrometer. The relevant skin lesion(s) will be excised and diagnosed as per routine treatment. | Device | SciBase III |
Primary outcome
SciBase Sensitivity and Specificity
Time frame: Post data lock
This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device: 1. Sensitivity ≥ 0.90 to detect Melanoma 2. Sensitivity - (1-Specificity) > 0.00 Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma.
1 secondary outcome
Sensitivity and Specificity
Time frame: Post data lock
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12877688Aberg P, Nicander I, Holmgren U, Geladi P, Ollmar S. Assessment of skin lesions and skin cancer using simple electrical impedance indices. Skin Res Technol. 2003 Aug;9(3):257-61. doi: 10.1034/j.1600-0846.2003.00017.x.
- Background: PubMed 15605856Aberg P, Nicander I, Hansson J, Geladi P, Holmgren U, Ollmar S. Skin cancer identification using multifrequency electrical impedance--a potential screening tool. IEEE Trans Biomed Eng. 2004 Dec;51(12):2097-102. doi: 10.1109/TBME.2004.836523.
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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.
Ulrik H Birgersson, PhD study director
SciBase and Karolinska Institutet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SciBase III Electrical Impedance Spectrometer in people with Malignant Melanoma, run by SciBase AB at 2 sites in 2 countries.
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 6 inclusion and 12 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 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Sweden. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
SciBase Sensitivity and Specificity (time frame: Post data lock). 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 NCT01077050, which also lists 2 linked publications.
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 30 Dec 2013.