Understanding diagnostic and prognostic factors in melanoma
BioMEL - a Translational Study About Aetiology, Diagnosis, Prognosis, Treatment, Biology and Biomarkers in Clinically Atypical Nevi and Melanoma.
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 4 sites (Helsingborg, Skåne County and 3 other locations) |
| Trial ID | NCT05446155 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing evaluation for suspicious pigmented skin lesions or those with confirmed metastatic melanoma.
Not a fit: Patients with very small lesions that could compromise histopathological diagnosis may not benefit from this study.
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 performed: Other studies have shown promise in understanding melanoma through similar observational approaches, indicating potential for success.
Eligibility criteria
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 this trial is running
Helsingborg, Skåne County and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.