BioMEL- Diagnostic and Prognostic Factors in Melanoma. (BioMEL)

January 22, 2024 updated by: Region Skane

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

See above.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
    • Skane
      • Helsingborg, Skane, Sweden, 252 23
        • Recruiting
        • Helsingborg Hospital
        • Contact:
      • Kristianstad, Skane, Sweden, 29133
        • Recruiting
        • Kristianstad Hospital
        • Contact:
      • Lund, Skane, Sweden, 22241
        • Recruiting
        • Lund University Hospital
        • Contact:
      • Malmö, Skane, Sweden, 21428
        • Recruiting
        • Skåne University Hospital Malmö
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants, clinical patients, recruited in the Southern Swedish health care region, Region Skane. Patients are recruited in the daily clinical practices in the departments of Dermatology, Surgery (including, ENT, Neuro, General surgery, Gynecology) and Oncology.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with a suspected primary melanoma or equivocal pigmented skin tumour
Patients, 18 years or older, 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. Imaging of tumours will be applied before surgery. Blood samples are taken before surgery. Tumour/normal skin biopsies will be taken and snap-frozen (-80°C) immediately after surgery. A baseline questionnaire about skin cancer risk factors, co-morbidities, phenotypic factors, diets, smoking, alcohol and quality of life will be given to the patient before surgery.
Diagnostic test: Imaging
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
Patients with secondary melanoma (metastatic disease)
Patients, 18 years or older, 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. Imaging of tumours will be applied before surgery. Blood samples are taken before surgery. Tumour biopsies will be taken and snap-frozen (-80°C) immediately after surgery. A baseline questionnaire about skin cancer risk factors, co-morbidities, phenotypic factors, diets, smoking, alcohol and quality of life will be given to the patient before surgery.
Diagnostic test: Imaging
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Cross sectional (subjects included november 2013- december 2026.
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.
Cross sectional (subjects included november 2013- december 2026.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Kari Nielsen, Ass. Prof., Lund University Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2013

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For now, only researchers involved in the project can access the data, but this can change after completion of the data gathering.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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