Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards

NCT ID: NCT05681949

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Fibrolamellar Hepatocellular Carcinoma Cholangiocarcinoma, Perihilar Intrahepatic Cholangiocarcinoma Metastasis to Liver Gallbladder Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Participants' cases discussed in tumor conference without ADBoard

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Participants' cases discussed in tumor conference with ADBoard

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

Group Type EXPERIMENTAL

ADBoard

Intervention Type OTHER

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

Interventions

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ADBoard

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Center for Artificial Intelligence

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Felix Krenzien

Senior Physician and Advanced Clinician Scientist, Charité - Universitätsmedizin Berlin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felix Krenzien

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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

Berlin, , Germany

Site Status

Countries

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Germany

Central Contacts

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Felix Krenzien

Role: CONTACT

+4930450552001

Facility Contacts

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Felix Krenzien

Role: primary

+4930450552001

References

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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.

Reference Type DERIVED
PMID: 37684688 (View on PubMed)

Other Identifiers

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EA4/169/22

Identifier Type: -

Identifier Source: org_study_id

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