RecruitingNCT05446155

BioMEL- Diagnostic and Prognostic Factors in Melanoma.

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


Sponsor

Region Skane

Enrollment

2,000 participants

Start Date

Nov 4, 2013

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting tissue, blood, and clinical data from patients with melanoma (a type of skin cancer) or suspected melanoma to discover new biological markers that could improve how the disease is diagnosed and how outcomes are predicted. **You may be eligible if...** - You are being evaluated or treated for a suspicious pigmented skin lesion that may be melanoma (primary part) - OR you are being evaluated for metastatic (spread) melanoma (secondary part) - You are receiving care at one of the participating hospitals in Sweden - You can provide written informed consent **You may NOT be eligible if...** - Your skin lesion is so small that taking a biopsy sample for the study would compromise the ability to diagnose it properly Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DIAGNOSTIC_TESTImaging

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


Locations(4)

Helsingborg Hospital

Helsingborg, Skåne County, Sweden

Kristianstad Hospital

Kristianstad, Skåne County, Sweden

Lund University Hospital

Lund, Skåne County, Sweden

Skåne University Hospital Malmö

Malmo, Skåne County, Sweden

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NCT05446155


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