Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT04510740

Recrutement en cours

JADE: Liver Cancer Registry Platform

Observationnel

Phase non listée

Multiple sites all over germany

Sponsor: iOMEDICO

Dernière synchronisation : 1 mai 2025

Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

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.

Afficher la description détaillée

Catégorie de traitement

Autres

Mutations requises

Aucun

Essai commencé

9 août 2020

Dernière mise à jour par le sponsor

1 mai 2025

Achèvement estimé

1 décembre 2027

Contact de l'étude

Nom:iOMEDICO AG

E-mail:info@iomedico.com

Téléphone:+49 761 15242-0

Éligibilité

Critères d'inclusion

* 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

Critères d'exclusion

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

Pensez-vous que cet essai apparaît incorrectement ?

Détails de la conception

AllocationN/A

Modèle d'interventionN/A

MasquageN/A

Nombre à inscrire1000

Bras et interventions

Bras

Interventions

Type : N/A

Description : Patients with Hepatocellular Carcinoma (HCC)

Interventions :

Physician's choice according to patient's needs.

Mesures des résultats

Mesures des résultats primaires

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

Documentation of anamnestic data and therapy sequences.

Mesures des résultats secondaires

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].

Mettre l'essai en favori

Partager l'essai

Télécharger l'essai

Pensez-vous que cet essai apparaît incorrectement ?

Signaler l'essai

Télécharger l'essai

Sites d'essai

Cette étude compte 1 site d'essai

Multiple sites all over germany

Multiple Locations, DE

Nom:iOMEDICO AG

Recrutement en cours

Multiple Locations, DE

Multiple sites all over germany

Loading Maps...