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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Andrea Casadei Gardini, Medical Oncologist
- Telefonszám: +390226437627
- E-mail: CasadeiGardini.Andrea@hsr.it
Tanulmányi helyek
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Milan, Olaszország
- Toborzás
- IRCCS Ospedale San Raffaele
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Kapcsolatba lépni:
- Andrea Casadei Gardini, Medical Oncologist
- Telefonszám: +390226437627
- E-mail: CasadeiGardini.Andrea@hsr.it
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
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).
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
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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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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To collect clinical data from patients with primary liver disease
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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To seek correlation between clinical and molecular data with PFS outcome
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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To seek potential immunological biomarker
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- SR Liver Cancer Registry
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