Feasibility Evaluation of See.d Pre-Analytical Platform Performance: From Whole Blood to Plasma and SBS Slides for Liquid Biopsy Applications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Feasibility of using See.d SBS slides for subsequent analysis
研究概览
简要总结
This study aims to evaluate the feasibility of using See.d instrument and SBS slides for preparation of plasma and cytological samples from whole blood.
Forty-five participants will be enrolled (20 healthy volunteers and 25 metastatic breast cancer patients) and each participant will be asked to provide a blood sample.
详细描述
The goal of this study is the evaluation of a new instrument called See.d, to be used in conjunction with its accessories, Smart Bio Surface (SBS) slides, for preparation of cytological samples (seeded on SBS slides) and plasma from fresh whole blood (within 4-6 hours from collection).
Blood samples collected from healthy volunteers will be spiked-in with reference DNA and mock-CTC to mimic a patient sample in order to evaluate the instrument performance through the analysis of several parameters.
Blood samples from Metastatic Breast Cancer (MBC) patients will be processed with See.d instrument installed in a clinical context to perform a preliminary analytical characterization of either cell-free DNA (cfDNA) and Circulating Tumor Cells (CTC).
For its feasibility nature, no formal statistics has been planned for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General (all participants)
- •Participants is willing and able to give and sign a written informed consent
- •Aged 18 or above
- •Specific for metastatic breast cancer patients
- •Female for metastatic breast cancer patients, aged 18 or above
- •Histological confirmation of breast cancer
- •Presence of at least one non-bone metastasis
- •Disease assessed to be in clinical or radiologic progression to the last line of treatment, as evaluated by the investigator
- •The biopsy, when recommended by the oncologist, is scheduled within 4 weeks after the date of blood withdrawal
- •Last biopsy or any other minor surgical procedure was perfomed at least 7 days before blood withdrawal
- •Known Bilirubin level ≥ 2 mg/dL on a blood sample collected within 7 days from the enrolment. If unavailable, it is not necessary to assess bilirubin
- •Specific for healthy participants
- •Both sexes for healthy volunteers, aged 18 or above
- •Healthy participants who visit the site for reason other than cancer diagnosis (including breast cancer).
排除标准
- •Ongoing infections requiring antibiotic or antiviral treatment
- •Previous history of a blood cancer or an invasive non-BC apart from cancers treated with curative intent at least 3 years previously with no recurrence since diagnosis with the exception of non-melanoma skin cancer. For healthy participants also includes breast cancer
- •Undergone major surgery < 4 weeks prior to the time of blood collection
- •Initiated a new line of treatment after disease progression at the time of blood or tissue biopsy collection
- •Presence of known severe coagulation or haematological disorder
- •Pregnancy
- •For metastatic breast cancer patients: histological confirmation of a Triple Negative Breast Cancer (TNBC)
研究组 & 干预措施
Healthy donors
Participants who are in good health and without history of cancer disease
Metastatic Breast Cancer patients
Metastatic breast cancer category is based on the definition of the European Society of Medical Oncology and is defined as disease spread to other parts of the body, such as bones, liver or lungs (also called stage IV). Tumours at distant sites are called metastases.
结局指标
主要结局
Feasibility of using See.d SBS slides for subsequent analysis
时间窗: 1 day (at the blood draw)
Recovery of putative Circulating Tumor Cells (CTCs)
cfDNA quality control
时间窗: 1 day (at the blood draw)
Evaluation of the ratio between cfDNA and genomic contaminant DNA
Feasibility of using See.d plasma for subsequent analysis
时间窗: 1 day (at the blood draw)
Detection of already known DNA mutations
Evaluation of White Blood Cells adhered on SBS slides
时间窗: 1 day (at the blood draw)
Evaluation of total adhered cell count on SBS slides
SBS slides stability
时间窗: 1 day (at the blood draw)]
Evaluation of the area of adhered cell nuclei on SBS slides
次要结局
未报告次要终点