Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards

NCT05681949 | Unknown

• 1 other identifier: EA4/169/22
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Completeness of the patient information with regard to decision-relevant parameters

  Through study completion, average of 30 months

• Quality of the explainability of the tumor conference protocols (ADBoard)

  Through study completion, average of 30 months

• Time between primary presentation and start of diagnostics/therapy as recommended

  Through study completion, average of 30 months

Study Arms (2)

Participants' cases discussed in tumor conference without ADBoard

NO INTERVENTION

Participants' cases are discussed in tumor conference without the use of ADBoard, according to conventional practice.

Participants' cases discussed in tumor conference with ADBoard

EXPERIMENTAL

Participants' cases will be evaluated by ADBoard directly before they are discussed in the tumor conference.

Other: ADBoard

Interventions

ADBoard OTHER

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

Participants' cases discussed in tumor conference with ADBoard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Research Center for Artificial Intelligence: collaborator

Study Sites (1)

Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Related Publications (1)

• Ng SST, Oehring R, Ramasetti N, Roller R, Thomas P, Chen Y, Moosburner S, Winter A, Maurer MM, Auer TA, Kamali C, Pratschke J, Benzing C, Krenzien F. Concordance of a decision algorithm and multidisciplinary team meetings for patients with liver cancer-a study protocol for a randomized controlled trial. Trials. 2023 Sep 9;24(1):577. doi: 10.1186/s13063-023-07610-8.

  PMID: 37684688 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Fibrolamellar hepatocellular carcinoma; Klatskin Tumor; Cholangiocarcinoma; Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases

Study Officials

• Felix Krenzien

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Krenzien

CONTACT

+4930450552001; felix.krenzien@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician and Advanced Clinician Scientist, Charité - Universitätsmedizin Berlin

Model Details: 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.

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 12, 2023
• Study Start: November 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)