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AzTrials

Gastric CancerNCT04675138

Development of a Clinical Decision Support System With Artificial Intelligence for Cancer Care

An observational study of Gastric Cancer and Esophageal Cancer, run by National University Hospital, Singapore at 9 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Clinical Decision Support Systems (CDSSs) to augment clinical care and decision making. These are platforms which aim to improve healthcare delivery by enhancing medical decisions with targeted clinical knowledge, patient information, and other health information. Read more about this study

Who is it for?
Ages 21 years and older
How many people
1,000 participants
Where
9 sitesin 6 countries
Study dates
20 Aug 2020to 31 Dec 2024
Phase
Observational
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The population will be selected from hospitals that conduct tumor board for these cancers

Who may be able to join

None listed.

Who cannot join

  • In discovery and internal retrospective validation part:
  • Patients with other primary cancers involving the stomach or oesophagus
  • Patients with other cancer subtypes
  • Patients with concomitant cancers of other organs
  • In prospective validation part:
  • Patients with esophageal squamous cell carcinoma
  • Patients who participate in clinical trials where the treatment modality is not standard of care

Trial locations and contacts

9 sites in 6 countries.

9 sites in 6 countries

Singapore4 sites, 4 recruiting
  • National University Hospital

    Singapore, 119228

    Jimmy So, MBChB, +65 6772 5555 ext. 24236, sursbyj@nus.edu.sg

    Recruiting
  • National Cancer Centre Singapore

    Singapore

    Matthew Ng, matthew.ng.c.h@singhealth.com.sg

    Matthew Ng

    Recruiting
  • Ng Teng Feng General Hospital

    Singapore

    Jun Liang Teh, teh_jun_liang@nuhs.edu.sg

    Jun Liang Teh

    Recruiting
  • Tan Tock Seng Hospital

    Singapore

    Myint Oo Aung, myint_oo_aung@ttsh.com.sg

    Myint Oo Aung

    Recruiting

Other trials in Singapore

Germany1 site, 1 recruiting
  • University Hospital Leipzig

    Leipzig

    Florian Lordick, Florian.Lordick@medizin.uni-leipzig.de

    Ines Gockel, Ines.Gockel@medizin.uni-leipzig.de

    Recruiting

Other trials in Germany

Japan1 site, 1 recruiting
  • National Cancer Centre Hospital East

    Kashiwa

    Takahiro KINOSHITA, takkinos@east.ncc.go.jp

    Takahiro KINOSHITA

    Recruiting

Other trials in Japan

South Korea1 site, 1 recruiting
  • Seoul National University Hospital

    Seoul

    Hyuk-Joon Lee, appe98@snu.ac.kr

    Hyuk-Joon Lee

    Recruiting

Other trials in South Korea

Sweden1 site, 1 recruiting
  • Karolinska Institute Hospital

    Stockholm

    Magnus Nilsson, magnus.nilsson@ki.se

    Mats Lindblad, mats.lindblad@regionstockholm.se

    Recruiting

Other trials in Sweden

United Kingdom1 site, 1 recruiting
  • The University of Edinburgh

    Edinburgh

    Chris Deans, Chris.Deans@nhslothian.scot.nhs.uk

    Chris Deans

    Recruiting

Other trials in United Kingdom

About this study

Clinical Decision Support Systems (CDSSs) to augment clinical care and decision making. These are platforms which aim to improve healthcare delivery by enhancing medical decisions with targeted clinical knowledge, patient information, and other health information.

In view of the benefit of developing a CDSS, we sought to develop an alternative CDSS for oncologic therapy selection through a partnership with Ping An Technology (Shenzhen, China), beginning with gastric and oesophagal cancer. This would be done in a piecemeal fashion, with the prototype platform utilizing only international guidelines and high-quality published evidence from journals to arrive at case-specific treatment recommendations. This platform would then be evaluated by comparing its recommendations with that from the multidisciplinary tumour boards of several tertiary care institutions to determine the concordance rate.

Read the detailed description

Management of cancer is a complex process which involves numerous stakeholders. In view of this, institutions worldwide have adopted the use of Multidisciplinary Tumor Boards (MTBs) for delivery of cancer care. By tapping on the collective specialized knowledge and experience of various specialties, MTBs have been shown in some studies to result in more appropriate recommendations and improved patient outcomes. At our institution, cancer cases are similarly discussed at regular MTBs which comprises surgeons, oncologists, pathologists and radiologists who review and recommend treatments.

However, in smaller centres or centres with limited resources and minimal multi-disciplinary expertise, delivery of timely and appropriate cancer care could be a challenge. Additionally, clinicians, with their busy schedule, may not be able to keep abreast of new developments in cancer research. With rapid advances in scientific research, this pool of knowledge is expected to continue to burgeon, making keeping up-to-date increasingly onerous.

To address this need, clinicians have adopted the use of Clinical Decision Support Systems (CDSSs) to augment clinical care and decision-making. These are platforms which aim to improve healthcare delivery by enhancing medical decisions with targeted clinical knowledge, patient information, and other health information. Various studies have shown CDSSs to be beneficial in selected settings such as patient safety and diagnosis [4], and to even increase adherence to clinical guidelines. In recent years, advancements in artificial intelligence have also seen its use expand to include oncologic therapy selection, with IBM's Watson for Oncology (WFO) being the most prominent and only platform in use to-date. In a 2018 study, WFO's ability to provide treatment advice for breast cancer was compared against recommendations from a multidisciplinary board, where it showed a high degree of concordance. Since then, several other studies have sought to examine WFO's ability to provide treatment recommendations for cancer such as ovarian, gastric, lung, cervical and colorectal cancers, with mixed results. In particular, both studies which examined the recommendations for gastric cancers showed a much lower concordance rate compared to other cancers.

In view of the above, we sought to develop an alternative CDSS for oncologic therapy selection through partnership with Ping An Technology (Shenzhen, China), beginning with gastric and esophageal cancer. This would be done in a piecemeal fashion, with the prototype platform utilizing only international guidelines and high-quality published evidence from journals to arrive at case-specific treatment recommendations. This platform would then be evaluated retrospectively and prospectively by comparing its recommendations with that from the multidisciplinary tumor boards of several tertiary care institutions to determine the concordance rate.

Being tested
No intervention will be provided to the subject
Keywords
Gastric Cancer, Esophageal Cancer, Artificial Intelligence, Multidisciplinary Tumor Board, Clinical Decision Support System, Concordance
Medical subject headings
Stomach Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention will be provided to the subjectOther

    No intervention will be provided to the subject

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concordance Rate

    Comparative agreement in recommendations between the two study groups, as measured by concordance rate

    Measured: 1 to 2 years

Secondary outcomes (1)
  1. Reason for Discordance

    To identify the reason for the discordance

    Measured: 1 to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2020
  2. Study start20 Aug 2020
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04675138
Sponsor's protocol ID
2020/00493
Status last verified
May 2024
First submitted
15 Dec 2020
Last updated
10 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Somashekhar SP, Sepulveda MJ, Puglielli S, Norden AD, Shortliffe EH, Rohit Kumar C, Rauthan A, Arun Kumar N, Patil P, Rhee K, Ramya Y. Watson for Oncology and breast cancer treatment recommendations: agreement with an expert multidisciplinary tumor board. Ann Oncol. 2018 Feb 1;29(2):418-423. doi: 10.1093/annonc/mdx781.

    PubMed 29324970

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer and Esophageal Cancer, run by National University Hospital, Singapore at 9 sites in 6 countries.

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 0 inclusion and 7 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 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Singapore, Germany, Japan, South Korea, Sweden and 1 more country. 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 Bok Yan, Jimmy So (+65 6772 5555 ext. 24236, sursbyj@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concordance Rate (time frame: 1 to 2 years). 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 NCT04675138, 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 10 Oct 2024.

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