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NCT Number: NCT05446155

BioMEL- Diagnostic and Prognostic Factors in 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.

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Key information

About this study

See above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imaging

Diagnostic Test

Diagnostic and prognostic imaging, omics and machine learning methods will be applied

Other names: transcriptomics, genomics, metabolomics, histopathological examination, deep and spatial sequencing, dermoscopy, machine learning methods

Primary outcomes

  1. Genomic and transcriptomic differences between cutaneous melanoma, melanoma in situ, dysplastic nevi and benign nevi.

    Time frame: Cross sectional (subjects included november 2013- december 2026.

    Genomic and transcriptomic differences as analysed from DNA and RNA collected from tumour tissue biopsies from cutaneous melanoma, melanoma in situ, dysplastic nevi and benign nevi.

  2. Interindividual genomic and transcriptomic differences in metastatic melanoma

    Time frame: Cross sectional (subjects included november 2013- december 2026.

    Genomic and transcriptomic differences as analysed from DNA and RNA collected from tumour tissue biopsies from metastatic melanoma.

Study contacts

Contact information is provided by the study sponsor or research team.

Kari Nielsen, Ass. Prof.

CONTACT

[email protected]

+46424061000

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

BioMEL - a Translational Study About Aetiology, Diagnosis, Prognosis, Treatment, Biology and Biomarkers in Clinically Atypical Nevi and Melanoma.

Acronym: BioMEL

Important dates

Study start
2013
Primary completion
2026
Study completion
2028
First posted
Jul 6, 2022
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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