BioMEL- Diagnostic and Prognostic Factors in Melanoma.

NCT05446155 | Recruiting

• 1 other identifier: 2013-101
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Melanoma; Melanoma in Situ; Dysplastic Nevi; Mole (Dermatology); Image; Mutation

Keywords

Biobank; Melanoma; nevus; mole; dermoscopy; dermatoscopy; skin cancer; Sequence analysis, DNA; Sequence analysis, RNA; Whole genome sequencing

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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

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

Interventions

Imaging DIAGNOSTIC_TEST

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

Also known as: transcriptomics, genomics, metabolomics, histopathological examination, deep and spatial sequencing, dermoscopy, machine learning methods

Patients with a suspected primary melanoma or equivocal pigmented skin tumour; Patients with secondary melanoma (metastatic disease)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with lesions, primary or secondary, that are so small that a punch biopsy for the study would risk affecting the histopathological diagnosis.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (4)

Helsingborg Hospital

Helsingborg, Skåne County, 252 23, Sweden

RECRUITING

Kristianstad Hospital

Kristianstad, Skåne County, 29133, Sweden

RECRUITING

Lund University Hospital

Lund, Skåne County, 22241, Sweden

RECRUITING

Skåne University Hospital Malmö

Malmo, Skåne County, 21428, Sweden

RECRUITING

Related Publications (1)

• Helkkula T, Christensen G, Ingvar C, Isaksson K, Harbst K, Persson B, Ingvar A, Hafstrom A, Carneiro A, Gaspar V, Jonsson G, Nielsen K. BioMEL: a translational research biobank of melanocytic lesions and melanoma. BMJ Open. 2024 Feb 2;14(2):e069694. doi: 10.1136/bmjopen-2022-069694.

  PMID: 38309755 DERIVED

Related Links

• BioMEL home page

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, tumour tissue samples (1 mm punch biopsy) from the primary tumour and normal, adjacent skin (2 mm punch biopsy). Tissue biopsies from melanoma metastases (excisional/punch biopsy)

MeSH Terms

Conditions

Melanoma; Dysplastic Nevus Syndrome; Nevus; Skin Neoplasms

Interventions

Diagnostic Imaging; Genome; Dermoscopy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Genetic Structures; Genetic Phenomena; Intravital Microscopy; Microscopy; Investigative Techniques

Study Officials

• Kari Nielsen, Ass. Prof.

  Lund University Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kari Nielsen, Ass. Prof.

CONTACT

+46424061000; kari.nielsen@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 6, 2022
• Study Start: November 4, 2013
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)