JOURNAL ONKOLOGIE – STUDIE

New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma (PERSUASION)- a Permanent Platform Including All Kind of Biliary Tract Cancers (BTC)

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT04896931

Studienbeginn:
Juli 2022

Letztes Update:
29.09.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Biliary Tract Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborator:
-

Studienleiter

Thorsten Götze, PD Dr.
Study Director
Krankenhaus Nordwest GmbH

Kontakt

Thorsten Götze, PD Dr.
Kontakt:
Phone: 0049 69 7601 4187
E-Mail: goetze.thorsten@KHNW.de» Kontaktdaten anzeigen

Lisa Kochen, Dr.
Kontakt:
Phone: 06976014391
E-Mail: kochen.lisa@ikf-khnw.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Krankenhaus Nordwest GmbH
60488 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Thorsten O Goetze, PD Dr.» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Permanent, prospective, multicenter registry including all kind of oncological therapy lines

and procedures, clinical outcome, translational research (biobanking) and QoL for all types

of biliary tract cancers. The registry does not define any medical intervention and does not

evaluate the efficacy or safety of the treatment decision made by the investigator. Every

adverse event whether related to a treatment or not, will neither be documented in the

trial´s eCRF nor be reported to the leading investigators of this study.

Objectives: • To establish a registry with a representative BTC-patient population in

German-speaking Europe (mainly DACH region) for current and future research. The study

registry is not based on a primary endpoint. The data collection includes (among basic

patient-/tumor-/treatment- characteristics) the survey of quality of life (EORTC-C30), a

so-called patient-reported outcome (PRO) and - if available - the collection of tissue

samples for translational accompanying projects.

- Clinical data:

- To analyse potential risk factors associated with BTC-cancer addressing clinical

and biological predictors of treatment success and survival

- To determine the course of disease and QoL throughout all applied therapy lines for

patients with BTC

- To measure progression-free, disease-free and overall survival in different BTC

sub-groups, mortality and morbidity for perioperative and palliative therapy

procedures

- Recording of the therapy regimens and therapy sequences used across all treatment

lines

- Molecular data (Data- and Biobanking):

- To establish a sample collection for future molecular/genetic biomarker

characterization to enable for e.g. assessment of the frequency of targetable

mutations and associated therapy decisions or progression analysis in baseline and

follow-up investigations

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Known biliary-tract cancer including intrahepatic-, extrahepatic- and gallbladder

carcinomas

- age ≥18 years

- signed informed consent form

- planned for (or recently started - i.e. within the last 21 days)) neoadjuvant,

adjuvant or 1st line therapy

Exclusion Criteria:

- Patients who are unable to consent because they do not understand the nature,

significance and implications of the registry and therefore cannot form a rational

intention

- Patient under 18 years of age

- Patient's inability to complete QoL questionnaire or answer the questions.

- Second-line or further palliative therapies if the patient's first-line therapy was

not documented within the study.

Studien-Rationale

Primary outcome:

1. Establishment of BTC population (Time Frame - Through study completion, an average of 2 years):
To establish a representative BTC-patient population in German-speaking Europe in an agile platform study design for future research

Secondary outcome:

1. analyse potential risk factors associated with BTC-cancer (Time Frame - Through study completion, an average of 2 years):
Correlate medical history with patient outcome, find prevalent medical history associated with BTC chancer

2. The course of Quality of Life (QoL) throughout the entire course of therapy for patients with BTC (Time Frame - Through study completion, an average of 2 years):
EORTC-QLQC30 according to EORTC scoring manual

3. PFS (Time Frame - Through study completion, an average of 2 years):
progression-free survival in different BTC subgroups and therapy lines. As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.

4. DFS (Time Frame - Through study completion, an average of 2 years):
disease-free survival in different BTC subgroups and therapy lines. As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.

5. OS (Time Frame - Through study completion, an average of 2 years):
overall survival in different BTC subgroups and therapy lines. As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.

6. mortality (Time Frame - Through study completion, an average of 2 years):
mortality for perioperative and palliative therapy procedures

7. morbidity (Time Frame - Through study completion, an average of 2 years):
morbidity for perioperative and palliative therapy procedures

8. establishment of sample collection (tumorblocks and blood) (Time Frame - Through study completion, an average of 2 years):
establish a sample collection for future molecular/genetic biomarker characterization

Quelle: ClinicalTrials.gov

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