San Raffaele Registry on Liver Cancer
This is a Retrospective and Prospective Observational Single-Center Study. The purpose is to collect all data to generate a registry of primary liver cancer (hepatocellular carcinoma and biliary tract carcinoma) of patients accessing to San Raffaele Hospital. An additional purpose is to identify novel biomarkers to better manage primary liver cancer patients, for whom additional biological samples will be collected.
A total of 4000 patients will be enrolled; for the prospective cohort: from protocol approval to the achievement of the last planned patients in the prospective cohort (2000 patients). The retrospective cohort will start from the year 2000.
Patients will be followed for 5 years of follow-up.
研究概览
地位
条件
详细说明
The object of the study is to collect all data from patients with primary liver diseases (hepatocellular carcinoma or BTC), investigating any correlation with clinical and/or molecular characteristics. As exploratory analysis, the project will explore the possible identification of any immunological, genetic, histological, cellular, molecular, and/or microbiological biomarker that could support patients' management.
Data collection of enrolled patients will cover all initial information regarding patient disease characteristics and profiling and all follow-up data available, included any data generated by other hospitals but referring to the disease studied. As this is an observational study, there will be no modification to any existing treatment pathways for patients. The only additional procedures are the collection of some biological samples at different timepoints (baseline, 3, 6, 9, 12 months and at disease progression):
- Additional blood volumes (approximately 30 mL) to collect during routinary blood exams
- Saliva
- Stool
Moreover, also tumor tissue will be investigated for exploratory analysis. In particular, tumor tissue collected according to normal clinical practice (baseline, eventually surgery, and/or re-biopsy), if still available after diagnostic purpose, will be analyzed to seek novel biomarkers. Additionally to FFPE archivial tumor tissue, exceeding fresh tumor tissue from diagnostic purpose, may be stored in other media other than paraffin (for example OTC).
A total of 4000 patients will be enrolled; for the prospective cohort: from protocol approval to the achievement of the last planned patients in the prospective cohort (2000 patients). The retrospective cohort will start from the year 2000.
Patients will be followed for 5 years of follow-up.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Andrea Casadei Gardini, Medical Oncologist
- 电话号码：+390226437627
- 邮箱：CasadeiGardini.Andrea@hsr.it
学习地点
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Milan、意大利
- 招聘中
- IRCCS Ospedale San Raffaele
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接触：
- Andrea Casadei Gardini, Medical Oncologist
- 电话号码：+390226437627
- 邮箱：CasadeiGardini.Andrea@hsr.it
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study. However, concerning the retrospective cohort, the large sample sizes needed and considering that the disease involved in this study affects elderly subjects with co-morbidities and presents a significant mortality rate based on the stage of the disease, deceased and untraceable patients will also be included.
- ≥18 years of age.
- Patients diagnosed with any subtype of biliary tract cancer (i.e. iCCA, pCCA, dCCA or GBC) at every stage and with all therapeutic indications.
- Patients diagnosed with hepatocellular carcinoma at every stage and treated with all therapeutic options.
Exclusion Criteria:
1. Patients without diagnosis of hepatocellular carcinoma or biliary tract cancer (BTC).
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Patients with diagnosis of primary liver cancer
Patients with diagnosis of hepatocellular carcinoma or biliary tract cancer presenting to IRCCS Ospedale San Raffaele will be included
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To collect clinical data from patients with primary liver disease
大体时间：From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years
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Collection of all clinical data from patients with primary liver disease
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From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To seek correlation between clinical and molecular data with PFS outcome
大体时间：From date of start of each treatment line until the date of first documented progression or date of death from any cause, assessed up to 12 months. Tumor assessments will be performed in accordance with clinical practice
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-Progression-free survival (PFS), defined as the time from the start of each treatment line to the first documented disease progression or death from any cause, whichever occurs first, according to RECIST version 1.1.
PFS will be assessed separately for each treatment line received by the patien
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From date of start of each treatment line until the date of first documented progression or date of death from any cause, assessed up to 12 months. Tumor assessments will be performed in accordance with clinical practice
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To seek correlation between clinical and molecular data with OS outcome
大体时间：From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years
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Overall survival, defined as the time from diagnosis to death from any cause.
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From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years
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To seek correlation between clinical and molecular data with Toxicity outcome
大体时间：From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years
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Frequency and severity of adverse events related to treatment, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v.6.
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From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years
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To seek correlation between clinical and molecular data with DFS outcome
大体时间：From date of surgery or complete response until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 5 years. Tumor assessments will be performed in accordance with clinical practice
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DFS: Time from complete response or radical surgery to disease recurrence or death from any cause
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From date of surgery or complete response until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 5 years. Tumor assessments will be performed in accordance with clinical practice
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To seek potential immunological biomarker
大体时间：Baseline, 3, 6, 9, 12 months, and at disease progression (PD)
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Changes in immunological biomarkers will be assessed through the evaluation of soluble factors (such as cytokines) and immunophenotype of circulating and tumor-resident immune cells.
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Baseline, 3, 6, 9, 12 months, and at disease progression (PD)
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To seek potential genetic biomarker
大体时间：Baseline, 3, 6, 9, 12 months, and at disease progression (PD)
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Prevalence and type of somatic genetic alterations in tumor tissue assessed with Next-Generation Sequencing (NGS).
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Baseline, 3, 6, 9, 12 months, and at disease progression (PD)
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To seek potential histological biomarker
大体时间：Baseline, 3, 6, 9, 12 months, and at disease progression (PD)
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Histological tumor features will be assessed using high-throughput approaches, including multiplexed immunohistochemistry (IHC), to explore novel prognostic and/or predictive biomarkers.
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Baseline, 3, 6, 9, 12 months, and at disease progression (PD)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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