Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2013-11-04
2028-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Imaging
Diagnostic and prognostic imaging, omics and machine learning methods will be applied
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.
Imaging
Diagnostic and prognostic imaging, omics and machine learning methods will be applied
Interventions
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Imaging
Diagnostic and prognostic imaging, omics and machine learning methods will be applied
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Kari Nielsen, Ass. Prof.
Role: PRINCIPAL_INVESTIGATOR
Lund University Cancer Centre
Locations
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Helsingborg Hospital
Helsingborg, Skåne County, Sweden
Kristianstad Hospital
Kristianstad, Skåne County, Sweden
Lund University Hospital
Lund, Skåne County, Sweden
Skåne University Hospital Malmö
Malmo, Skåne County, Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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BioMEL home page
Other Identifiers
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2013-101
Identifier Type: -
Identifier Source: org_study_id
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