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Trial Title:
Artificial Intelligence and Cancer Staging in Upper Gastrointestinal Malignancies
NCT ID:
NCT05648084
Condition:
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
esophageal and stomach cancer patients over 18 years old diagnosed in 2 centers in van
turkey, Van Training and Research Hospital and Van Yuzuncu Yıl University.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Van Yuzuncu Yil University
Address:
City:
VAN
Zip:
65
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
sebahattin celik, associate professor
Phone:
00905057057957
Email:
scelik@yyu.edu.tr
Start date:
December 15, 2022
Completion date:
July 2024
Lead sponsor:
Agency:
Sebahattin Celik MD
Agency class:
Other
Source:
Yuzuncu Yıl University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05648084