Clinical trial NCT05446155: BioMEL- Diagnostic and Prognostic Factors in Melanoma.
Official title: BioMEL - a Translational Study About Aetiology, Diagnosis, Prognosis, Treatment, Biology and Biomarkers in Clinically Atypical Nevi and Melanoma.
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: See above.

Eligibility criteria: 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.

Primary outcomes:
measure: Genomic and transcriptomic differences between cutaneous melanoma, melanoma in situ, dysplastic nevi and benign nevi.
timeFrame: Cross sectional (subjects included november 2013- december 2026.
measure: Interindividual genomic and transcriptomic differences in metastatic melanoma
timeFrame: Cross sectional (subjects included november 2013- december 2026.
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
state: Skane
city: Kristianstad
country: Sweden
facility: Kristianstad Hospital
state: Skane
city: Lund
country: Sweden
facility: Lund University Hospital
state: Skane
city: Malmö
country: Sweden
facility: Skåne University Hospital Malmö
state: Skane
Study officials:
affiliation: Lund University Cancer Centre
name: Kari Nielsen, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References: