Understanding diagnostic and prognostic factors in melanoma
Official title: BioMEL - a Translational Study About Aetiology, Diagnosis, Prognosis, Treatment, Biology and Biomarkers in Clinically Atypical Nevi and Melanoma.
Run by Region Skane · NCT05446155 · Data updated 2026-11-12
This study is trying to find out how different types of skin growths, like melanoma and benign moles, affect patients by looking at their medical history and collecting blood samples.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Region Skane Academic / other |
| Locations | 4 sites (Helsingborg, Skåne County and 3 other locations) |
| Status | Recruiting |
| Started | November 4, 2013 |
| Main results expected | December 2026 |
| Study ends | December 2028 |
| Registry record updated | January 23, 2024 |
| Trial ID | NCT05446155 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients undergoing evaluation for suspicious pigmented skin lesions or those with confirmed metastatic melanoma.
✕Probably not a fit
Patients with very small lesions that could compromise histopathological diagnosis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the clinical, molecular, and genotypic differences among cutaneous melanoma, melanoma in situ, dysplastic nevi, and benign nevi. Patients suspected of having primary or secondary melanoma will participate by completing a validated questionnaire that covers their medical history, UV exposure, family cancer history, and lifestyle factors. Blood samples will be collected before surgical excisions and during follow-up for those with secondary disease to analyze potential biomarkers. The study is conducted across multiple hospitals in Skåne, Sweden.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of melanoma characteristics, leading to improved diagnostic and prognostic strategies for patients.
How similar studies have gone: Other studies have shown promise in understanding melanoma through similar observational approaches, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Patients with lesions, primary or secondary, that are so small that a punch biopsy for the study would risk affecting the histopathological diagnosis.
Where it's running
-
Helsingborg Hospital
Helsingborg, Skåne County, Sweden Recruiting -
Kristianstad Hospital
Kristianstad, Skåne County, Sweden Recruiting -
Lund University Hospital
Lund, Skåne County, Sweden Recruiting -
Skåne University Hospital Malmö
Malmö, Skåne County, Sweden Recruiting
Study contacts
- Principal investigator: Kari Nielsen, Ass. Prof. — Lund University Cancer Centre
- Study coordinator: Kari Nielsen, Ass. Prof.
- Email: kari.nielsen@med.lu.se
- Phone: +46424061000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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A computer tool called DEXI tested with DermaGraphix Visualizer helps dermatologists see if a skin lesion might be melanoma and aims to reduce unnecessary biopsies.
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Non-invasive skin-tape test to detect melanoma using methylation biomarkers
A non-invasive skin-tape test is being tried to see if it can detect melanoma in people who are about to have a biopsy for a suspicious pigmented lesion.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.