Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896931
Status:
RECRUITING
Last Update Posted:
2023-09-29
First Post:
2021-05-10
Brief Title:
New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma PERSUASION- a Permanent Platform Including All Kind of Biliary Tract Cancers BTC
Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Organization:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study Overview
Official Title:
New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma PERSUASION- a Permanent Platform Including All Kind of Biliary Tract Cancers BTC
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 trials 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 moleculargenetic biomarker characterization to enable for eg assessment of the frequency of targetable mutations and associated therapy decisions or progression analysis in baseline and follow-up investigations
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 moleculargenetic biomarker characterization to enable for eg assessment of the frequency of targetable mutations and associated therapy decisions or progression analysis in baseline and follow-up investigations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None