Skin Tumor Biomarkers by Mass Spectrometry Imaging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- creation of a diagnostic model capable of identifiying SCC and BCC areas in removed skin sections from BCC and SCC Mohs surgery.
研究概览
简要总结
The purpose of the study is to investigate the ability of mass spectrometry imaging to locate aggregates of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) ex-vivo, and to distinguish areas containing these carcinomas from normal skin. It is suggested that non-melanoma skin cancer (NMSC) cells show a different profile of endogenous lipids than healthe skin tissue which can be used as identifying biomarkers. If that hypothesis is correct it will be possible in the future to develop real-time tissue diagnosis and treatment of NMSC using mass spectrometry guided surgery.
Method
between 60 and 100 patients with BCCs, SCCs, and actinic keratoses (AK) will be recruited.
For patients referred for Mohs surgical procedure at the Department of Dermatology, Bispebjerg Hospital, to treat BCCs or SCCs, three skin sections (5-10 um thick) of the tissue that is already removed will be use in our study. One section will be HE stained so we know exactly where the regions of interest are. Two sections will be used for MS analysis (MSI spectrum and REIMS spectrum).
When patients are referred for a procedure to have treated several actinic keratoses (grade 1, 2 or 3) at Department of Dermatology, Bispebjerg Hospital we will take an extra punch biopsy (2-4 mm) depending on the size of the lesion. The biopsy is embedded and sectioned. We will use 3 skin sections (5-10 um thick) we will again use one section for HE staining and two for MS analysis.
Multivariate statistical analysis will be performed on all mass spectra using Matlab or similar program. Linear discriminant analysis will be used to identify spectral differences between pre-malignant, cancer and normal tissue. Classification performance will be recorded with a leave-one- patient- out cross- validation scheme.
详细描述
- Title Skin tumor biomarkers by mass spectrometry imaging
- Aim 2.1 Problem definition More than 1 million patients were diagnosed with non-melanoma skin cancer (NMSC) worldwide in 2018 and this number could be underestimated due to the lack of registries or incomplete registration of this type of cancer [1]. Timely detection of microscopic tumors is of utmost importance in cancer diagnostics. We believe that mass spectrometry imaging (MSI) can successfully locate microscopic aggregates of a common skin cancer, basal cell carcinoma (BCC) and squamous cell carcinoma (SCC), and distinguish them from adjacent normal skin ex-vivo. MSI unveils an altered chemical profile in BCC and SCC region (lipid patterns) and does not rely on visual identification of histopathologic features.
2.2 Hypothesis We hypothesize that NMSC cells exhibit specific, endogenous biomarkers (lipid patterns) that differ from healthy skin tissue in sections of skin biopsies. If that hypothesis is correct it will be possible in the future to develop real-time tissue diagnosis and treatment of NMSC using mass spectrometry guided surgery.
2.3 Outcome measures
- Identification of masses and distributions of selected lipid biomarkers in sections from removed BCC and SCC tissue from Mohs surgery.
- Identification of masses and distributions of selected lipid biomarkers in sections from biopsies with actinic keratoses (pre-malignant lesions).
2.4 Background The incidence of non-melanoma skin cancer (NMSC) was of 1 million people in 2018, according to the Skin Cancer Report of 2019 by World Cancer Research Fund, being classified as the more commonly occurring cancer worldwide [1]. The NMSC englobes primarily basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
In Denmark and other Western countries the occurrence of these tumors is also high [2], and Danish incidence continue to rise, amounting to 15.000 per year. The main risk factor to NMSC is exposure to ultraviolet radiation (UVR). Light skin color, light or red hair, light eye color and immunocompromised people are other established causes to NMSC [1,3].
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 18 years of age.
- •Patients presenting with AKs, SCCs and BCCs.
- •Written informed consent obtained from patient.
排除标准
- •Immunosuppressed patients
结局指标
主要结局
creation of a diagnostic model capable of identifiying SCC and BCC areas in removed skin sections from BCC and SCC Mohs surgery.
时间窗: after evaluation of samples form at least 180 patients, estimated 4-5 years
Establishment of model for detection and identification of basal cell carcinoma tissue and squamous cell carcinoma from healthy tissue by multivariate statistical analysis of lipid biomarkers detected with mass spectrometry imaging. The findings of the method will be compared to pathological designation of cancerous tissue to evaluate the applicability of the model
creation of a diagnostic model capable of identifiying areas with actinic keratoses in sections from biopsies with actinic keratoses (pre-malignant lesions).
时间窗: after evaluation of samples form at least 180 patients, estimated 4-5 years
Establishment of model for detection and identification of actinic keratoses from healthy tissue by multivariate statistical analysis of lipid biomarkers detected with mass spectrometry imaging. The findings of the method will be compared to pathological designation of cancerous tissue to evaluate the applicability of the model.
次要结局
未报告次要终点
研究者
Catharina Margrethe Lerche
MSc Pharm, PhD
Bispebjerg Hospital