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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05446155
Recruitment Status : Recruiting
First Posted : July 6, 2022
Last Update Posted : September 6, 2022
Sponsor:
Information provided by (Responsible Party):
Region Skane

Study Description
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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.


Condition or disease Intervention/treatment
Melanoma Melanoma in Situ Dysplastic Nevi Mole (Dermatology) Image Mutation Diagnostic Test: Imaging

Detailed Description:
See above.
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BioMEL - a Translational Study About Aetiology, Diagnosis, Prognosis, Treatment, Biology and Biomarkers in Clinically Atypical Nevi and Melanoma.
Actual Study Start Date : November 4, 2013
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


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)

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05446155


Contacts
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Contact: Kari Nielsen, Ass. Prof. +46424061000 kari.nielsen@med.lu.se

Locations
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Sweden
Helsingborg Hospital Recruiting
Helsingborg, Skane, Sweden, 252 23
Contact: Kari Nielsen, Ass. Prof.    +46424061000    kari.nielsen@med.lu.se   
Kristianstad Hospital Recruiting
Kristianstad, Skane, Sweden, 29133
Contact: Kari Nielsen, Ass. Prof.    +46424061000    kari.nielsen@med.lu.se   
Lund University Hospital Recruiting
Lund, Skane, Sweden, 22241
Contact: Kari Nielsen, Ass. Prof.    +46424061000    kari.nielsen@med.lu.se   
Skåne University Hospital Malmö Recruiting
Malmö, Skane, Sweden, 21428
Contact: Kari Nielsen, Ass. Prof.    +46424061000    kari.nielsen@med.lu.se   
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Kari Nielsen, Ass. Prof. Lund University Cancer Centre
More Information
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Additional Information:

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT05446155    
Other Study ID Numbers: 2013-101
First Posted: July 6, 2022    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: For now, only researchers involved in the project can access the data, but this can change after completion of the data gathering.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Skane:
Biobank
Melanoma
nevus
mole
dermoscopy
 dermatoscopy
skin cancer
Sequence analysis, DNA
Sequence analysis, RNA
Whole genome sequencing
Additional relevant MeSH terms:
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Melanoma
Dysplastic Nevus Syndrome
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nevus
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn