Идёт набор NCT07704489

San Raffaele Registry on Liver Cancer

— Наблюдательное Liver and Intrahepatic Biliary Tract Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Liver and Intrahepatic Biliary Tract Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Первичные конечные точки

To collect clinical data from patients with primary liver disease [Срок оценки: From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years]

Вторичные конечные точки (4)

To seek correlation between clinical and molecular data with PFS outcome [Срок оценки: 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]
To seek correlation between clinical and molecular data with OS outcome [Срок оценки: From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years]
To seek correlation between clinical and molecular data with Toxicity outcome [Срок оценки: From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years]
To seek correlation between clinical and molecular data with DFS outcome [Срок оценки: 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]

Критерии участия

Критерии включения

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.