Clinical trial NCT05681949: Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards
Official title: Evaluation of the Trustworthiness of the Application of Artificial Intelligence and Decision Support Systems for the Creation of Tumor Conference Protocols
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Fibrolamellar Hepatocellular Carcinoma
Cholangiocarcinoma, Perihilar
Intrahepatic Cholangiocarcinoma
Metastasis to Liver
Gallbladder Carcinoma
Keywords: decision support systems, clinical
tumor conference
tumor board
multidisciplinary team meeting
artificial intelligence
machine learning
natural language processing
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Center for Artificial Intelligence
First posted: 2023-01-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.


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

Primary outcomes:
measure: Concordance (yes/no) of interdisciplinary tumor conference treatment recommendation with ADBoard-supported recommendation
timeFrame: Through study completion, average of 30 months
measure: The reproducibility of the therapy recommendations made by ADBoard (yes/no)
timeFrame: Through study completion, average of 30 months
Secondary outcomes:
measure: Completeness of the patient information with regard to decision-relevant parameters
timeFrame: Through study completion, average of 30 months
measure: Quality of the explainability of the tumor conference protocols (ADBoard)
timeFrame: Through study completion, average of 30 months
measure: Time between primary presentation and start of diagnostics/therapy as recommended
timeFrame: Through study completion, average of 30 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Felix Krenzien
role: PRINCIPAL_INVESTIGATOR
References: