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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04896931
• Other study ID #: PERSUASION
• Status: Recruiting
• Start date: July 12, 2022
• Est. completion date: September 2029

Study information

• Verified date: September 2023
• Source: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Contact: Thorsten Götze, PD Dr.
• Phone: 0049 69 7601 4187
• Email: goetze.thorsten[@]KHNW.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2029
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Locations

Country	Name	City	State
Germany	Krankenhaus Nordwest GmbH	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of BTC population	To establish a representative BTC-patient population in German-speaking Europe in an agile platform study design for future research	Through study completion, an average of 2 years
Secondary	analyse potential risk factors associated with BTC-cancer	Correlate medical history with patient outcome, find prevalent medical history associated with BTC chancer	Through study completion, an average of 2 years
Secondary	The course of Quality of Life (QoL) throughout the entire course of therapy for patients with BTC	EORTC-QLQC30 according to EORTC scoring manual	Through study completion, an average of 2 years
Secondary	PFS	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.	Through study completion, an average of 2 years
Secondary	DFS	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.	Through study completion, an average of 2 years
Secondary	OS	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.	Through study completion, an average of 2 years
Secondary	mortality	mortality for perioperative and palliative therapy procedures	Through study completion, an average of 2 years
Secondary	morbidity	morbidity for perioperative and palliative therapy procedures	Through study completion, an average of 2 years
Secondary	establishment of sample collection (tumorblocks and blood)	establish a sample collection for future molecular/genetic biomarker characterization	Through study completion, an average of 2 years