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

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: Melanoma; Mutation; Image; Dysplastic Nevi; Melanoma in Situ; Mole (Dermatology)
• Intervention / Treatment: Diagnostic test: Imaging

Detailed Description

See above.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Kari Nielsen, Ass. Prof.; Phone Number: +46424061000; Email: kari.nielsen@med.lu.se

Study Locations

• Sweden
  • Skane
    • Helsingborg, Skane, Sweden, 252 23
      • Recruiting
      • Helsingborg Hospital
      • Contact: Kari Nielsen, Ass. Prof.; Phone Number: +46424061000; Email: kari.nielsen@med.lu.se
    • Kristianstad, Skane, Sweden, 29133
      • Recruiting
      • Kristianstad Hospital
      • Contact: Kari Nielsen, Ass. Prof.; Phone Number: +46424061000; Email: kari.nielsen@med.lu.se
    • Lund, Skane, Sweden, 22241
      • Recruiting
      • Lund University Hospital
      • Contact: Kari Nielsen, Ass. Prof.; Phone Number: +46424061000; Email: kari.nielsen@med.lu.se
    • Malmö, Skane, Sweden, 21428
      • Recruiting
      • Skåne University Hospital Malmö
      • Contact: Kari Nielsen, Ass. Prof.; Phone Number: +46424061000; Email: kari.nielsen@med.lu.se

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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.	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	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

• Sponsor: Region Skane
• Investigators: Principal Investigator: Kari Nielsen, Ass. Prof., Lund University Cancer Centre

Publications and helpful links

Helpful Links

• BioMEL home page

Study record dates

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: Biobank; Melanoma; Whole genome sequencing; skin cancer; nevus; mole; dermoscopy; dermatoscopy; Sequence analysis, DNA; Sequence analysis, RNA
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Genetic Diseases, Inborn; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Syndromes, Hereditary; Neuroendocrine Tumors; Nevi and Melanomas; Nevus; Melanoma; Dysplastic Nevus Syndrome
• 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