Hepatocellular CarcinomaADBoardNCT05681949
Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards
A study testing ADBoard in people with Hepatocellular Carcinoma and Fibrolamellar Hepatocellular Carcinoma, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Fibrolamellar Hepatocellular Carcinoma, Cholangiocarcinoma, Perihilar
- What is being tested?
- ADBoard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin
Berlin, 13353
Felix Krenzien, +4930450552001, felix.krenzien@charite.de
Christian Benzing
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma, Fibrolamellar Hepatocellular Carcinoma, Cholangiocarcinoma, Perihilar, Intrahepatic Cholangiocarcinoma, Metastasis to Liver, Gallbladder Carcinoma
- Being tested
- ADBoard
- Keywords
- decision support systems, clinical, tumor conference, tumor board, multidisciplinary team meeting, artificial intelligence, machine learning, natural language processing
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrolamellar hepatocellular carcinoma, Klatskin Tumor, Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADBoardOther
Utilizing the clinical decision support system 'ADBoard' for therapy selection in participants with hepatobiliary tumors
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ADBoard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Through study completion, average of 30 months
Secondary outcomes (3)
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.
Measured: Through study completion, average of 30 months
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.
Measured: Through study completion, average of 30 months
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.
Measured: Through study completion, average of 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study startNov 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Center for Artificial Intelligence
- Responsible party
- Principal investigator, Felix Krenzien, Charite University, Berlin, Germany
- Investigators
- Felix Krenzien, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681949
- Sponsor's protocol ID
- EA4/169/22
- Acronym
- ADBoard
- Status last verified
- Aug 2023
- First submitted
- 13 Dec 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37684688
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Trustworthiness of the Application of Artificial Intelligence and Decision Support Systems for the Creation of Tumor Conference Protocols
- ClinicalTrials.gov ID
- NCT05681949
- Acronym / sponsor ID
- ADBoard / EA4/169/22
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Center for Artificial Intelligence
- Study start
- Nov 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: ADBoardParticipants' cases will be evaluated by ADBoard directly before they are discussed in the tumor conference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADBoardUtilizing the clinical decision support system 'ADBoard' for therapy selection in participants with hepatobiliary tumors | Other | Participants' cases discussed in tumor conference with ADBoard |
Primary outcome
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.
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.
3 secondary outcomes
Completeness of the patient information with regard to decision-relevant parameters
Time frame: 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
Time between primary presentation and start of diagnostics/therapy as recommended
Time frame: Through study completion, average of 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Derived from this study: PubMed 37684688Ng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Krenzien principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADBoard in people with Hepatocellular Carcinoma and Fibrolamellar Hepatocellular Carcinoma, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix Krenzien (+4930450552001, felix.krenzien@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance (yes/no) of interdisciplinary tumor conference treatment recommendation with ADBoard-supported recommendation (time frame: Through study completion, average of 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05681949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.