Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT04510740

Rekrutiert

JADE: Liver Cancer Registry Platform

Beobachtungsstudie

Phase nicht angegeben

Multiple sites all over germany

Sponsor: iOMEDICO

Zuletzt aktualisiert: 1. Mai 2025

Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Hepatocellular Carcinoma (HCC) or Cholangiocarcinoma (CCC) in Germany.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Andere

Erforderliche Mutationen

Keine

Studie gestartet

9. August 2020

Zuletzt vom Sponsor aktualisiert

1. Mai 2025

Voraussichtlicher Abschluss

1. Dezember 2027

Studienkontakt

Name:iOMEDICO AG

E-Mail:info@iomedico.com

Telefon:+49 761 15242-0

Eignung

Einschlusskriterien

* Confirmed hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) als early, intermediate or advanced/metastatic stage

* Age ≥ 18 years

* Signed and dated informed consent (IC):

* For participation in the PRO module: Before primary locoregional therapy or start of first systemic treatment

* For no participation in the PRO module: No later than 8 weeks after primary locoregional therapy or start of first systemic treatment

Ausschlusskriterien

Patients treated with best supportive care (BSC) only (i.e. no surgery, no radiotherapy, no ablative procedures, no systemic anti-tumoral therapies)

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Design-Details

ZuteilungN/A

InterventionsmodellN/A

MaskierungN/A

Anzahl der Teilnehmer1000

Arme & Interventionen

Arme

Interventionen

Typ: N/A

Beschreibung: Patients with Hepatocellular Carcinoma (HCC)

Interventionen:

Physician's choice according to patient's needs.

Ergebnismessungen

Primäre Ergebnismessungen

Course of treatment (treatment reality).3 years per patient.

Documentation of anamnestic data and therapy sequences.

Sekundäre Ergebnismessungen

Best Response.3 years per patient.

Documentation of response rates per line of treatment.

Progression-free survival.3 years per patient.

Documentation of progression-free survival per line of treatment.

Overall survival.3 years per patient.

Documentation of overall survival per line of treatment.

Health-related quality of life (Patient-reported outcome, PRO).3 years per patient.

EORTC QLQ-C30 core questionnaire [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high scale score represents a higher response level: (a) global health status: a high score represents high quality of life, (b) functional scales: a high score represents high/healthy level of functioning, (c) symptom scales/items: a high score represents high level of symptomatology or problems]

Carcinoma Health-related quality of life (Patient-reported outcome, PRO).3 years per patient.

EORTC QLQ-HCC18, the hepatocellular carcinoma specific module / EORTC QLQ-BIL21, the cholangiocarcinoma specific module [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high score for scales and single items represents a high level of symptomatology or problems].

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Studienzentren

Diese Studie hat 1 Studienzentrum

Multiple sites all over germany

Multiple Locations, DE

Name:iOMEDICO AG

Rekrutierend

Multiple Locations, DE

Multiple sites all over germany

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