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

NCT ID: NCT04675138

Last Updated: 2024-10-10

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

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-20

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastric Cancer Esophageal Cancer Esophagogastric Junction Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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No intervention will be provided to the subject

No intervention will be provided to the subject

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

A. In discovery and internal retrospective validation part:

1. Patients with other primary cancers involving the stomach or oesophagus
2. Patients with other cancer subtypes
3. Patients with concomitant cancers of other organs

B. In prospective validation part:

1. Patients with esophageal squamous cell carcinoma
2. Patients who participate in clinical trials where the treatment modality is not standard of care
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Leipzig

Leipzig, , Germany

Site Status RECRUITING

National Cancer Centre Hospital East

Kashiwa, , Japan

Site Status RECRUITING

National University Hospital

Singapore, , Singapore

Site Status RECRUITING

National Cancer Centre Singapore

Singapore, , Singapore

Site Status RECRUITING

Ng Teng Feng General Hospital

Singapore, , Singapore

Site Status RECRUITING

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Karolinska Institute Hospital

Stockholm, , Sweden

Site Status RECRUITING

The University of Edinburgh

Edinburgh, , United Kingdom

Site Status RECRUITING

Countries

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Germany Japan Singapore South Korea Sweden United Kingdom

Central Contacts

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Bok Yan, Jimmy So

Role: CONTACT

+65 6772 5555 ext. 24236

Facility Contacts

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Florian Lordick

Role: primary

Ines Gockel

Role: backup

Takahiro KINOSHITA

Role: primary

Jimmy So, MBChB

Role: primary

+65 6772 5555 ext. 24236

Matthew Ng

Role: primary

Jun Liang Teh

Role: primary

Myint Oo Aung

Role: primary

Hyuk-Joon Lee

Role: primary

Magnus Nilsson

Role: primary

Mats Lindblad

Role: backup

Chris Deans

Role: primary

References

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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.

Reference Type RESULT
PMID: 29324970 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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2020/00493

Identifier Type: -

Identifier Source: org_study_id

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