BioMEL: a translational research biobank of melanocytic lesions and melanoma.
Teo Helkkula, Gustav Christensen, Christian Ingvar...
https://pubmed.ncbi.nlm.nih.gov/38309755Actively Recruiting
Led by Region Skane · Updated on 2024-01-23
2000
Participants Needed
4
Research Sites
104 weeks
Total Duration
Researchers are exploring the differences in clinical, molecular, and genetic features among cutaneous melanoma, melanoma in situ, dysplastic nevi, and benign nevi. The study also seeks to understand biological aggressiveness and find objective diagnostic markers for both primary and secondary melanoma. It includes patients suspected of having primary melanoma or metastatic melanoma and collects detailed information to support this research. Participants are adults receiving routine dermatological, surgical, or oncological care who are scheduled for surgical excision or cytological diagnostics of pigmented skin lesions or metastatic melanoma. Before surgery, imaging and blood samples are collected. During surgery, skin punch biopsies of the lesion and nearby normal skin are taken and stored frozen. Tissue samples from metastatic melanoma are also collected through biopsies during treatment and follow-up. Participants complete questionnaires about risk factors, medical history, lifestyle, and quality of life. Researchers document lesions with imaging and collect histology and molecular data stored securely. The study measures genomic and transcriptomic differences across melanoma types and tracks these findings over time. The total participation period spans from initial inclusion through follow-up, with samples and data collected before, during, and after treatments.
CONDITIONS
BioMEL- Diagnostic and Prognostic Factors in Melanoma.
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before surgery or biopsy
Participants undergo imaging and provide blood samples before surgery or biopsy to evaluate their condition.
1 visit (in-person) before surgery or biopsy
Duration - Single day procedure
Participants have surgical excision or biopsy of the pigmented skin lesion or metastatic melanoma with tissue samples collected for analysis.
1 visit (in-person) for surgery or biopsy
Duration - Same day as surgical procedure
Biopsies and blood samples are collected and preserved for genomic and transcriptomic analysis.
Samples collected during surgery visit
Duration - Up to 13 years
Participants are followed over time to monitor genomic and transcriptomic differences related to melanoma and related conditions.
Visits as part of routine clinical care; no additional trial visits required
Total: 4 locations
1
Helsingborg Hospital
Helsingborg, Skåne County, Sweden, 252 23
Actively Recruiting
2
Kristianstad Hospital
Kristianstad, Skåne County, Sweden, 29133
Actively Recruiting
3
Lund University Hospital
Lund, Skåne County, Sweden, 22241
Actively Recruiting
4
Skåne University Hospital Malmö
Malmö, Skåne County, Sweden, 21428
Actively Recruiting
K
Kari Nielsen, Ass. Prof.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Teo Helkkula, Gustav Christensen, Christian Ingvar...
https://pubmed.ncbi.nlm.nih.gov/38309755