NCT04675138

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
6 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 10, 2024

Status Verified

May 1, 2024

Enrollment Period

4.4 years

First QC Date

December 15, 2020

Last Update Submit

October 8, 2024

Conditions

Gastric CancerEsophageal CancerEsophagogastric Junction Cancer

Keywords

Gastric CancerEsophageal CancerArtificial IntelligenceMultidisciplinary Tumor BoardClinical Decision Support SystemConcordance

Outcome Measures

Primary Outcomes (1)

  • Concordance Rate

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

    1 to 2 years

Secondary Outcomes (1)

  • Reason for Discordance

    1 to 2 years

Interventions

No intervention will be provided to the subjectOTHER

No intervention will be provided to the subject

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • A. 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
  • B. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University Hospital Leipzig

Leipzig, Germany

RECRUITING

National Cancer Centre Hospital East

Kashiwa, Japan

RECRUITING

National University Hospital

Singapore, 119228, Singapore

RECRUITING

National Cancer Centre Singapore

Singapore, Singapore

RECRUITING

Ng Teng Feng General Hospital

Singapore, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Karolinska Institute Hospital

Stockholm, Sweden

RECRUITING

The University of Edinburgh

Edinburgh, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29324970RESULT

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Central Study Contacts

Bok Yan, Jimmy So

CONTACT

+65 6772 5555sursbyj@nus.edu.sg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 19, 2020

Study Start

August 20, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 10, 2024

Record last verified: 2024-05

Locations

DE(1)SE(1)SG(4)GB(1)KR(1)JP(1)