MelanomaFLIMMANCT02425475
FLuorescence Identification of Melanoma by a Multicenter Based Algorithm (FLIMMA)
An observational study of Melanoma and Moles, run by University Hospital Tuebingen at 3 sites in Germany.
Trial summary
All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- LIMES
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 3 sitesGermany
- Study dates
- Aug 2014to Dec 2016
- 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: This study evaluates patients with pigmented lesions, which are excised in order to exclude or diagnose cutaneous melanoma.
Who may be able to join
- Patients ≥ 18 years of age
- Male or female
- Patients having pigmented lesions with suspicion of dysplastic nevus or melanoma, in whom an excision is performed in order to exclude or diagnose malignant melanoma
- Patients who gave their written informed consent.
Who cannot join
- Patients with skin type V and VI according to Fitzpatrick's scale;
- Where there is a risk that the scanning head is torn off be-cause the patient cannot be placed at rest (e.g. due to motoric disorders like tremor, convulsions, tics, compulsive acts
- Patients who cannot understand the patient information and provide informed consent
- Deep dermal lesions ≥ 5 mm beneath the stratum corneum
- Clinically or reflected-light microscopically obviously non-melanocytic lesions
- Peri- and subungual lesions
Show all 13Show fewer
- Mucosal lesions
- Lesions with trauma, erosion (superficial defect), excoriation (defect down to the basement membrane) or ulceration (deep substantial defect) on more than 50 % of the lesion area (measurements must in any case not be carried out directly on the trauma, erosion, excoriation or ulceration)
- Tattooed lesions
- Pregnant or breast feeding women
- Patients suffering from albinism
- Lesions with dominant (>50%) regression
- Lesions which are not suitable to fix the scanning cap
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Dept. of Dermatology, Charité
Berlin, 10117
Dept. of Dermatology, University Hospital
Heidelberg, 69120
Dept. of Dermatology, University Hospital
Tübingen, 72076
About this study
Official title: A Prospective, Non-controlled, Multicenter Clinical Study to Evaluate the Diagnostic Accuracy of the Stepwise Two Photon Excited Melanin Fluorescence of Potentially Malignant Pigmented Lesions as Compared to Histopathological Diagnosis
All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histopathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.
- Being tested
- LIMES
- Keywords
- Dermoscopy
- Medical subject headings
- Melanoma, Nevus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIMESDevice
All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histo-pathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.
| Study group | Role | What they receive |
|---|---|---|
| Mole | Patients with suspicious moles Receives: Device: LIMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine sensitivity and specificity of the algorithm for the fluorescence diagnostics of melanoma.
The comparator and gold standard for the diagnosis will be the histopathological diagnosis of the pigmented lesions.
Measured: 7 days
Secondary outcomes (1)
To collect data for training and optimization of the diagnostic algorithm.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startAug 2014
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Claus Garbe, MD, Principal investigator, Dept. of Dermatology, University Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425475
- Sponsor's protocol ID
- FLIMMA-01
- Acronym
- FLIMMA
- Status last verified
- May 2017
- First submitted
- 2 Apr 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hofmann MA, Keim U, Jagoda A, Forschner A, Fink C, Spankuch I, Tampouri I, Eigentler T, Weide B, Haenssle HA, Garbe C. Dermatofluoroscopy diagnostics in different pigmented skin lesions: Strengths and weaknesses. J Dtsch Dermatol Ges. 2020 Jul;18(7):682-690. doi: 10.1111/ddg.14163. Epub 2020 Jul 12.
PubMed 32657017Fink C, Hofmann M, Jagoda A, Spaenkuch I, Forschner A, Tampouri I, Lomberg D, Leupold D, Garbe C, Haenssle HA. Study protocol for a prospective, non-controlled, multicentre clinical study to evaluate the diagnostic accuracy of a stepwise two-photon excited melanin fluorescence in pigmented lesions suspicious for melanoma (FLIMMA study). BMJ Open. 2016 Dec 19;6(12):e012730. doi: 10.1136/bmjopen-2016-012730.
PubMed 27993903
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-controlled, Multicenter Clinical Study to Evaluate the Diagnostic Accuracy of the Stepwise Two Photon Excited Melanin Fluorescence of Potentially Malignant Pigmented Lesions as Compared to Histopathological Diagnosis
- ClinicalTrials.gov ID
- NCT02425475
- Acronym / sponsor ID
- FLIMMA / FLIMMA-01
- Keywords
- Dermoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, Charite University, Berlin, Germany
- Study start
- Aug 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Apr 2015 (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.
All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histopathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mole | – | Device: LIMESPatients with suspicious moles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study evaluates patients with pigmented lesions, which are excised in order to exclude or diagnose cutaneous melanoma.
Key inclusion criteria (4 listed)
- Patients ≥ 18 years of age
- Male or female
- Patients having pigmented lesions with suspicion of dysplastic nevus or melanoma, in whom an excision is performed in order to exclude or diagnose malignant melanoma
- Patients who gave their written informed consent.
Key exclusion criteria (13 listed)
- Patients with skin type V and VI according to Fitzpatrick's scale;
- Where there is a risk that the scanning head is torn off be-cause the patient cannot be placed at rest (e.g. due to motoric disorders like tremor, convulsions, tics, compulsive acts
- Patients who cannot understand the patient information and provide informed consent
- Deep dermal lesions ≥ 5 mm beneath the stratum corneum
- Clinically or reflected-light microscopically obviously non-melanocytic lesions
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 |
|---|---|---|
| LIMESAll patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histo-pathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy. | Device | Mole |
Primary outcome
To determine sensitivity and specificity of the algorithm for the fluorescence diagnostics of melanoma.
Time frame: 7 days
The comparator and gold standard for the diagnosis will be the histopathological diagnosis of the pigmented lesions.
1 secondary outcome
To collect data for training and optimization of the diagnostic algorithm.
Time frame: 1 day
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 May 2017.
- Derived from this study: PubMed 32657017Hofmann MA, Keim U, Jagoda A, Forschner A, Fink C, Spankuch I, Tampouri I, Eigentler T, Weide B, Haenssle HA, Garbe C. Dermatofluoroscopy diagnostics in different pigmented skin lesions: Strengths and weaknesses. J Dtsch Dermatol Ges. 2020 Jul;18(7):682-690. doi: 10.1111/ddg.14163. Epub 2020 Jul 12.
- Derived from this study: PubMed 27993903Fink C, Hofmann M, Jagoda A, Spaenkuch I, Forschner A, Tampouri I, Lomberg D, Leupold D, Garbe C, Haenssle HA. Study protocol for a prospective, non-controlled, multicentre clinical study to evaluate the diagnostic accuracy of a stepwise two-photon excited melanin fluorescence in pigmented lesions suspicious for melanoma (FLIMMA study). BMJ Open. 2016 Dec 19;6(12):e012730. doi: 10.1136/bmjopen-2016-012730.
Related trials for Melanoma
Enrolling by invitationObservational study
Community Based Strategies for Early Detection of Melanoma
Melanoma
Active, not recruitingPhase 3
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
RecruitingObservational study
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Melanoma, Dysplastic Nevus Syndrome
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer
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.
Claus Garbe, MD principal investigator
Dept. of Dermatology, University Hospital Tübingen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Moles, run by University Hospital Tuebingen at 3 sites 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 4 inclusion and 13 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 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
To determine sensitivity and specificity of the algorithm for the fluorescence diagnostics of melanoma. (time frame: 7 days). 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 NCT02425475, 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 3 May 2017.