跳至主要内容
临床试验/NCT05446155
NCT05446155招募中不适用

BioMEL - a Translational Study About Aetiology, Diagnosis, Prognosis, Treatment, Biology and Biomarkers in Clinically Atypical Nevi and Melanoma.

Region Skane4 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2013年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Region Skane
入组人数
2,000
试验地点
4
主要终点
Interindividual genomic and transcriptomic differences in metastatic melanoma

研究概览

简要总结

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.

详细描述

See above.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Interindividual genomic and transcriptomic differences in metastatic melanoma

时间窗: 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.

Genomic and transcriptomic differences between cutaneous melanoma, melanoma in situ, dysplastic nevi and benign nevi.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (4)

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