Studying skin moles and melanoma to find better diagnostic markers
Collects skin samples, blood and imaging from people with suspected or confirmed melanoma.
Plain-language title generated from the registry record
Registry title: BioMEL- Diagnostic and Prognostic Factors in Melanoma.
Key facts
- Where
- Helsingborg, Kristianstad, Lund, and Malmö, SwedenSee the 4 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are planned for surgery or needle sampling because of a suspicious pigmented skin lesion or a melanoma that has spread.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Either a skin spot that could be a primary melanoma or a similar condition, or a melanoma that has spread (metastatic melanoma).
Main reasons for not taking part
- Lesions, primary or secondary, that are so small that a punch biopsy could affect the diagnosis under the microscope.
Read by machine on 12 November 2026.
Where in Sweden
- Helsingborg hospitalHelsingborg, SwedenContact: Kari Nielsen, Ass. Prof.Taking people
- Kristianstad HospitalKristianstad, SwedenContact: Kari Nielsen, Ass. Prof.Taking people
- Lund University HospitalLund, SwedenContact: Kari Nielsen, Ass. Prof.Taking people
- Skane University Hospital MalmöMalmö, SwedenContact: Kari Nielsen, Ass. Prof.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Region Skane
- Trial code
- NCT05446155
- Record updated
- 23 January 2024
- Original description
The investigators' hypothesis is that cutaneous melanoma, melanoma in situ, dysplastic nevi and benign nevi all differ in not only clinical characteristics but also molecular and genotypic characteristics.Read full original descriptionShow less
BioMEL - a Translational Study About Aetiology, Diagnosis, Prognosis, Treatment, Biology and Biomarkers in Clinically Atypical Nevi and Melanoma.
The investigators' hypothesis is that cutaneous melanoma, melanoma in situ, dysplastic nevi and benign nevi all differ in not only clinical characteristics but also molecular and genotypic characteristics.
Patients with suspected primary cutaneous melanoma or a differential diagnosis, or secondary melanoma can be asked to participate in the first part of the project and patients with suspected or confirmed secondary (spread) melanoma can be included in the second part of the study. Participants included in the study answer a validated questionnaire regarding epidemiological and phenotypic factors to map medical history, prior UV exposure, family history of melanoma and/or other cancer types, skin type, smoking habits, alcohol use and quality of life.
Blood samples (whole blood) are collected before primary local excision and before secondary surgical procedures as well as during follow up of patients with secondary disease and oncologic treatment. During local excision of the primary pigmented skin lesion, full-thickness skin punch biopsies are taken by trained dermatologists. The biopsies, in the lesion and next to the lesion in the normal skin of the suspected melanoma, are taken, snap frozen and stored deep frozen. The primary lesions are documented by accurate imaging methods prior to excision.
Tissue samples from suspected or confirmed secondary melanomas are collected mainly through surgical and core needle biopsies before, during and after treatment and in case of disease progress or treatment failure. Tissue samples are snap-frozen and stored in the same way as samples from primary melanomas.
Comprehensive questionnaire based, imaging-based information, as well as histologic information provided from the pathologist report is included and stored in a secure database.
All the information in the database, along with information from molecular analysis of tissue and/or blood samples will then be used to find objective, molecular and clinical differences in melanoma, melanoma in situ, dysplastic and benign nevi along with potential information of biological aggressivity of both primary and secondary melanoma in order to find more objective diagnostic markers.
Inclusion: Primary part of the project: Patients in dermatological outpatient routine care in Helsingborg, Lund or Malmö Hospitals. Patients are planned for surgical excision for an equivocal pigmented skin lesion that could be a primary melanoma or a differential diagnosis of melanoma; Secondary part of the project: . Patient, in surgical or oncological routine care in Helsingborg, Lund, Malmö or Kristianstad Hospitals. Patients are planned for surgical excision or cytological diagnostics (needle aspiration) of metastatic melanoma; All subjects have to be able to provide written informed consent.
Exclusion: Patients with lesions, primary or secondary, that are so small that a punch biopsy for the study would risk affecting the histopathological diagnosis.