Artificial Intelligence and Cancer Staging in Upper Gastrointestinal Malignancies

Sponsor
Sebahattin Celik MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05648084
Collaborator
(none)
200
1
11.5
17.3

Study Details

Study Description

Brief Summary

Esophageal and stomach cancers, which constitute cancers of the upper region of the digestive system, are cancers that are frequently observed and unfortunately have a low rate of cured patients. In these cases, the stage of cancer at diagnosis is very important for two reasons; First, the stage of the cancer is directly related to the survival time. Secondly, treatment is planned according to the stage. Different treatments are applied to patients at different stages. Currently, the TNM staging (Tumor, Lymph Node and Metastases) system is the accepted one worldwide. Despite many advanced technology tools used in staging (Computed Tomography, Magnetic Resonance Imaging, Endoscopic Ultrasonography), there are still difficulties in correct staging before surgery or before-after neoadjuvant therapy. Artificial intelligence techniques are increasingly used in the field of health, especially in the diagnosis and treatment of cancers. Obtaining cancer details in radiological images, which cannot be noticed by the human eye, by analyzing big data with the help of algorithms gave rise to the application area of "radiomics". It is stated that with Radiomics, there will be improvements in both the diagnosis and staging of cancers and, accordingly, in the treatment. While there are studies on the use of endoscopic methods with artificial intelligence for the early diagnosis of esophageal cancers, a limited number of studies have been conducted on stage estimation from radiological images. In particular, there are not enough studies on the investigation of changes in tumor size after chemotherapy with artificial intelligence and the estimation of staging. In this study, it was aimed to investigate the predictive efficiency of staging and the accuracy of the algorithm developed with artificial intelligence by processing tomography images in a region where esophageal cancers are endemic as a primary outcome and to evaluate the post-treatment mortality, morbidity rates and complication rates of the patients as a secondary outcome.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    To Investigate the Predictive Efficiency of Staging by Processing Tomography Images in Esophageal and Stomach Malignancies
    Actual Study Start Date :
    Dec 15, 2022
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Artificial intelligence's sensitivity and accuracy to predict the stage of the cancer [1 year]

      to investigate the predictive efficiency of staging and the accuracy of the algorithm developed with artificial intelligence by processing tomography images in a region where esophageal cancers are endemic

    Secondary Outcome Measures

    1. to evaluate the post-treatment mortality, morbidity rates and complication rates of the patients [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    1. Being diagnosed with esophageal cancer (adenocarcinoma or squamous cancer)

    2. Being over 18 years old

    3. Having a tomography image before or after chemotherapy.

    4. Giving informed consent to participate in the study.

    5. Having final pathological staging after surgery.

    Exclusion Criteria:
    1. Previous thoracic surgery.

    2. Having a recurrent tumor

    3. Inability to perform clinical staging due to technical reasons

    4. Drawings cannot be made due to poor tomography quality.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Van Yuzuncu Yil University VAN Turkey 65

    Sponsors and Collaborators

    • Sebahattin Celik MD

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sebahattin Celik MD, Associate Professor, Yuzuncu Yıl University
    ClinicalTrials.gov Identifier:
    NCT05648084
    Other Study ID Numbers:
    • 2021-667-19/20210502
    First Posted:
    Dec 13, 2022
    Last Update Posted:
    Jan 4, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 4, 2023