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NLP to Aid in the Evaluation and Diagnosis of FGIDs

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05501028
Collaborator
Massachusetts Institute of Technology (Other)
700
Enrollment
1
Location
57.7
Anticipated Duration (Months)
12.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study has two arms, where the same natural language processing (NLP) and probabilistic graphical modeling technology will be utilized on patients' report of symptoms in both arms. The clinical arm is focused on patients presenting for consultation with a gastroenterologist. The endoscopy arm is focused generally on patients presenting for a diagnostic endoscopy, with the goal of capturing Functional Gastrointestinal Disorder (FGID) patients prior to diagnosis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Using Natural Language Processing of Novel Biopsychosocial Disease Constructs to Aid in the Evaluation and Diagnosis of Functional Gastrointestinal Disorders
    Actual Study Start Date :
    Aug 9, 2018
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients scheduled for consult with gastroenterologist
    Patients scheduled for diagnostic endoscopy

    Outcome Measures

    Primary Outcome Measures

    1. Latent themes present in patient descriptions of FGIDs symptoms [08/09/2018-08/09/2023]

      Latent themes present in patient descriptions of FGIDs symptoms as generated by machine learning as well as quantitative comparisons to traditional metrics of patient descriptions including Rome IV criteria and patient descriptions of severity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Scheduled for consult in the Motility Clinic in the MGH Gastroenterology Unit or for diagnostic endoscopy in the MGH Gastroenterology Unit

    • Patient must agree to have their interactions audio-recorded

    • Informed consent form signed by the subjects

    Exclusion Criteria:

    • Non-native English speaker

    • Patients unable to communicate their own symptoms

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Massachusetts Institute of Technology

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyle Staller, MD, MPH, Principal Investigator, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT05501028
    Other Study ID Numbers:
    • 2018P001542
    First Posted:
    Aug 15, 2022
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gastrointestinal Diseases
    Digestive System Diseases

    Study Results

    No Results Posted as of Aug 15, 2022