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临床试验/NCT05637788
NCT05637788进行中(未招募)不适用

Artificial Intelligence and Hepatocellular Carcinoma

Humanitas Clinical and Research Center1 个研究点 分布在 1 个国家目标入组 535 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
535
试验地点
1
主要终点
Evaluate the association between different radiomics and computer-vision features, and the survival after surgery

研究概览

简要总结

To identify new relevant biomarkers for HCC patients and their risk of recurrence. Radiomics data and computer-vision data will be explored for their ability to predict the presence of particular pathological signs of aggressiveness (microvascular invasion and satellitosis), and the prognosis after surgery.

详细描述

Hepatocellular carcinoma (HCC) is 1 of the 5 most common malignancies worldwide and the third most common cause of cancer related mortality of 500,000 deaths globally every year.

Although more common in East Asia, the incidence of HCC is increasing in the Western world. Hepatic resection is the first-line therapeutic option, and it is accepted as a safe treatment with a proven impact on prognosis, with a low operative mortality as the result of advances in surgical techniques and perioperative management. Nevertheless, surgical resection is applicable in only about 20% to 30% of patients with HCC, since most have poor hepatic reserve function caused by underlying chronic liver disease and multi focal hepatic distributions of HCC. Although hepatic resection is one of the curative treatments for hepatocellular carcinoma, the recurrence rate of HCC even after curative resection is quite high, estimated to be approximately 50 % during the first 3 years and more than 70 % during the first 5 years after curative resection, and so the postoperative long term results remain unsatisfactory. In this scenario the role of liver transplantation has been, in the last years, predominant, due to the ability of transplant to reduce disease recurrence, because of the treatment of liver cirrhosis associate to HCC which represent the most important driver to recurrence. Otherwise, the scarcity of organ source has been a boost to the spread of liver resection, not only confined in the boundary taken into account in the BCLC algorithm (guidelines endorsed by EASL and AASLD), but even in patients considered not suitable for curative treatment as well as liver resection. Although surgical treatment has been adopted in the last years in more patients outside the Guidelines with satisfactory results in terms of mortality, morbidity and Short term oncological outcomes, the limits of this approach remain the long term disease free survival.

Risk factor for recurrence has been yet identified in the last years as hcc dimension, grading, microvascular invasion and satellitosis. The evidence that these two prognostic factors could negatively impact on the long term prognosis enhancing the risk of recurrence, has led many Author to propose anatomical resection (segmental resection) as the ideal surgical treatment to reduce these risks in HCC patients. Otherwise, literature results are in conflict regarding the real benefit of this approach. In fact in many patients with HCC and underlying cirrhosis the anatomical approach is not feasible due to the risk of postoperative liver failure. So a parenchyma-sparing technique has been developed and compared to anatomical resection in terms of oncological outcomes. At the present, all these risk factors are not predictable, and the staging systems are based only on crude radiological features as the number and the size of the nodules. In the recent years, several authors proposed new approaches to increase our ability to extract data from the radiological imaging: by the analysis of the measurements and numbers obtained during the radiological acquisition (by CT or MRI scans), thousands of other information are obtainable, overcoming the ability of human eyes. Those techniques go under the names of "Radiomics", which is a very promising branch when merged with the novel machine learning algorithms (e.g. Deep Learning, Neural Networks, etc). Moreover, nowadays, novel data can be obtained also by simple intraoperative photo obtained during the surgical procedure, for example of the liver cut surface: by the "computer-vision analysis", another powerful machine-learning algorithm, other data can be produced to predict short and long term outcomes. Those potentialities rely on the modern field of "artificial intelligence", where a machine is trained to recognize different recurrent patterns to create prediction models with a very powerful accuracy. On these data is based the proposal to create the present multicentric study with the aim to develop a prediction model for post-operative complications and HCC recurrence, based on the analysis of CT-radiomics features, liver cut surface photos and machine learning analysis.

研究设计

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

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

  • Age >= 18 years old.
  • Hepatocarcinoma diagnosis confirmed at histological specimen
  • Being at the first HCC diagnosis or with a recurrence/persistence disease evaluated and treated for the first time with surgery at the participating center.
  • Available contrast-enhanced CT Scan obtained no more than 1 month prior to surgery.

排除标准

  • Surgery as a downstaging therapy for transplant
  • Patients treated with surgery in case of not-curative intent (palliation, best supportive care, etc).
  • Histopathological specimen of combined liver primary neoplasms (e.g. 'epatocolangiocarcinoma').

结局指标

主要结局

Evaluate the association between different radiomics and computer-vision features, and the survival after surgery

时间窗: 1 Year and 4 Months

Evaluate the association between different radiomics (obtained by the pre-operative CT scans) and computer-vision (obtained by the photos of the remnant liver after surgery) features, and the survival after surgery (in terms of Recurrence-Free Survival and Overall Survival). Thus, to develop a prediction algorithm based on that features.

次要结局

  • Evaluate the association between different radiomics and computer-vision features, and the short-terms results after surgery(1 Year and 4 Months)

研究者

发起方
Humanitas Clinical and Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Famularo, MD

Principal Investigator

Humanitas Clinical and Research Center

研究点 (1)

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