Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards (ADBoard)

August 22, 2023 updated by: Felix Krenzien, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin
        • Contact:
        • Sub-Investigator:
          • Christian Benzing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients whose cases are discussed at hepatobiliary tumor conferences

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Participants' cases discussed in tumor conference without ADBoard
Participants' cases are discussed in tumor conference without the use of ADBoard, according to conventional practice.
Experimental: Participants' cases discussed in tumor conference with ADBoard
Participants' cases will be evaluated by ADBoard directly before they are discussed in the tumor conference.
Other: ADBoard
Utilizing the clinical decision support system 'ADBoard' for therapy selection in participants with hepatobiliary tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance (yes/no) of interdisciplinary tumor conference treatment recommendation with ADBoard-supported recommendation
Time Frame: Through study completion, average of 30 months

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
The reproducibility of the therapy recommendations made by ADBoard (yes/no)
Time Frame: Through study completion, average of 30 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness of the patient information with regard to decision-relevant parameters
Time Frame: Through study completion, average of 30 months
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
Time between primary presentation and start of diagnostics/therapy as recommended
Time Frame: Through study completion, average of 30 months
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
Quality of the explainability of the tumor conference protocols (ADBoard)
Time Frame: Through study completion, average of 30 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Research Center for Artificial Intelligence

Investigators

  • Principal Investigator: Felix Krenzien, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4/169/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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