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Search / Trial NCT05446155

BioMEL- Diagnostic and Prognostic Factors in Melanoma.

Launched by REGION SKANE · Jul 1, 2022

Trial Information

Current as of June 28, 2025

Recruiting

Keywords

Biobank Melanoma Nevus Mole Dermoscopy Dermatoscopy Skin Cancer Sequence Analysis, Dna Sequence Analysis, Rna Whole Genome Sequencing

ClinConnect Summary

The BioMEL trial is studying different types of skin conditions related to melanoma, including primary melanoma, melanoma in situ (early-stage melanoma), and certain types of moles. The goal is to understand how these conditions differ not only in their appearance but also at a genetic level. By gathering information from patients about their medical history, sun exposure, family background, and lifestyle habits, researchers hope to identify unique markers that could help in diagnosing and determining the aggressiveness of these skin conditions.

To participate in the trial, you may be eligible if you are seeing a dermatologist for a suspicious skin lesion that might be melanoma or if you have been diagnosed with metastatic melanoma (cancer that has spread). Participants will provide blood samples and undergo skin biopsies, where small samples of both the suspicious lesion and surrounding normal skin will be collected. All information will be carefully stored and analyzed to improve understanding and treatment of melanoma. If you decide to join, you will be contributing to important research that could help future patients.

Gender

ALL

Eligibility 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.

About Region Skane

Region Skåne is a leading healthcare authority in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to fostering collaboration between researchers, healthcare professionals, and patients, Region Skåne aims to enhance the understanding of various health conditions and develop effective treatment strategies. With a focus on ethical standards and patient safety, the organization plays a pivotal role in shaping the future of healthcare in the region and beyond, ensuring that clinical trials are conducted with the highest level of scientific rigor and transparency.

Locations

Helsingborg, Skane, Sweden

Kristianstad, Skane, Sweden

Lund, Skane, Sweden

Malmö, Skane, Sweden

Patients applied

0 patients applied

Trial Officials

Kari Nielsen, Ass. Prof.

Principal Investigator

Lund University Cancer Centre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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