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Trial Title:
Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards
NCT ID:
NCT05681949
Condition:
Hepatocellular Carcinoma
Fibrolamellar Hepatocellular Carcinoma
Cholangiocarcinoma, Perihilar
Intrahepatic Cholangiocarcinoma
Metastasis to Liver
Gallbladder Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Cholangiocarcinoma
Klatskin Tumor
Conditions: Keywords:
decision support systems, clinical
tumor conference
tumor board
multidisciplinary team meeting
artificial intelligence
machine learning
natural language processing
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The ADBoard study is a monocentric, prospective, parallel randomized controlled trial
with a non-inferiority framework. Participants will be randomized 1:1 into one of two
groups: either a) tumor conference with ADBoard, or b) tumor conference without ADBoard.
Primary purpose:
Health Services Research
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
ADBoard
Description:
Utilizing the clinical decision support system 'ADBoard' for therapy selection in
participants with hepatobiliary tumors
Arm group label:
Participants' cases discussed in tumor conference with ADBoard
Summary:
The goal of this observational study is to compare the recommendations of the artificial
intelligence clinical decision support system 'ADBoard', with the recommendations of
physicians by tumor conferences in patients with hepatobiliary tumors. The main questions
it aims to answer are:
Can ADBoard achieve a high level of similar recommendations as physicians' tumor
conferences? Can ADBoard consider a more complete set of patient-related data than in
physicians' tumor conferences? Can ADBoard reduce the time between the first time the
patient is discussed at the tumor conference and the start of the recommended treatment
plan? Participants will have their hepatobiliary tumor treatments determined by either
tumor conference with ADBoard, or tumor conference without ADBoard.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 years
- Valid informed consent
- Patient information available in the hospital information system or Health Data
Platform (HDP)
- Enrollment in the hepatobiliary tumor conference
- Diagnosis of any of the following entities: Colorectal liver metastasis, Gallbladder
carcinoma, Hepatocellular carcinoma (HCC), mixed cell carcinoma, or fibrolamellar
carcinoma, Perihilar cholangiocarcinoma (Klatskin tumors), Intrahepatic
cholangiocarcinoma (iCC)
Exclusion Criteria:
- Patient does not consent / incapable of giving consent
- Missing findings in the hospital information system
- Patient is seeking for a second opinion and is not being treated at the study
institution
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Contact:
Last name:
Felix Krenzien
Phone:
+4930450552001
Email:
felix.krenzien@charite.de
Investigator:
Last name:
Christian Benzing
Email:
Sub-Investigator
Start date:
November 2023
Completion date:
July 2025
Lead sponsor:
Agency:
Charite University, Berlin, Germany
Agency class:
Other
Collaborator:
Agency:
German Research Center for Artificial Intelligence
Agency class:
Other
Source:
Charite University, Berlin, Germany
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05681949
