Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards

Hepatocellular Carcinoma Clinical Trial

— ADBoard  

Official title:

Evaluation of the Trustworthiness of the Application of Artificial Intelligence and Decision Support Systems for the Creation of Tumor Conference Protocols

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05681949
• Other study ID #: EA4/169/22
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: July 2025

Study information

• Verified date: August 2023
• Source: Charite University, Berlin, Germany
• Contact: Felix Krenzien
• Phone: +4930450552001
• Email: felix.krenzien[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Cholangiocarcinoma, Perihilar
• Fibrolamellar Hepatocellular Carcinoma
• Gallbladder Carcinoma
• Hepatocellular Carcinoma
• Intrahepatic Cholangiocarcinoma
• Klatskin Tumor
• Metastasis to Liver

Intervention

Other:
• ADBoard
Utilizing the clinical decision support system 'ADBoard' for therapy selection in participants with hepatobiliary tumors

Locations

Country	Name	City	State
Germany	Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Research Center for Artificial Intelligence

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance (yes/no) of interdisciplinary tumor conference treatment recommendation with ADBoard-supported recommendation	Examples of possible treatment recommendations are liver resection (curative), regimen of chemotherapy, immunotherapy, radiotherapy, transarterial chemoembolisation, diagnostics, best-supportive care, follow-up by re-presentation.; The interrater reliability of the recommendations of ADBoard and the tumor conferences with regard to their agreement will be measured.	Through study completion, average of 30 months
Primary	The reproducibility of the therapy recommendations made by ADBoard (yes/no)	The intrarater reliability will be measured by testing all participant cases several times by the ADBoard according to the required sample size with sufficient statistical power (test-retest). Interrater and intrarater reliability will be evaluated descriptively (percentage of agreement, contingency tables), and finally the Cohen-Kappa value will be assessed.	Through study completion, average of 30 months
Secondary	Completeness of the patient information with regard to decision-relevant parameters	For each type of tumor examined, a series of relevant parameters is defined by the medical staff. The objective is achieved if complete documentation, defined as documentation status 'present' or 'detected as missing', is present in more than or equal to 75% of all ADBoard-assisted decisions.	Through study completion, average of 30 months
Secondary	Quality of the explainability of the tumor conference protocols (ADBoard)	The System Causability Scale will be reviewed by 3 specialist physicians. The score ranges from 0 to 1. A higher score means greater suitability of the user interface, explanation, or explanation process itself for the intended purpose of tumor conference treatment recommendations.	Through study completion, average of 30 months
Secondary	Time between primary presentation and start of diagnostics/therapy as recommended	The time between the initial presentation of the case to the tumor conference and the time of recommendation implementation will be recorded.	Through study completion, average of 30 months