Actively Recruiting

Age: 18Years +
All Genders
ID05446155

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

Led by Region Skane · Updated on 2024-01-23

2000

Participants Needed

4

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

BioMEL- Diagnostic and Prognostic Factors in Melanoma.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older in dermatological outpatient care at specified hospitals
  • Patients planned for surgical excision of an equivocal pigmented skin lesion possibly a primary melanoma or related diagnosis
  • Patients in surgical or oncological routine care planned for excision or biopsy of metastatic melanoma
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Patients with lesions too small for punch biopsy without risking histopathological diagnosis accuracy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Surgical Biopsy or Excision

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

Sample Collection

Duration - Same day as surgical procedure

Biopsies and blood samples are collected and preserved for genomic and transcriptomic analysis.

Samples collected during surgery visit

Long-term Monitoring

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

Trial Site Locations

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

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Research Team

K

Kari Nielsen, Ass. Prof.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial