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Brief Title: Evaluation of the Diagnostic Potential of Artificial Intelligence-assisted Fecal Microbiome Testing for Colon Cancer
Official Title: Comparison of the Diagnostic Potential of Colonoscopy, and Artificial Intelligence-assisted Fecal Microbiome Testing for Colon Cancer
Study ID: NCT05795725
Brief Summary: The goal of this clinical trial is to evaluate the diagnostic potential of Artificial Intelligence-assisted Fecal Microbiome Testing for the diagnosis of colon cancer. The main question it aims to answer is: ⢠Is Artificial Intelligence-assisted Fecal Microbiome Testing a reliable screening test for colon cancer? Participants will be asked to provide fecal samples to be analyzed with next-generation sequencing techniques. If there is a comparison group: Researchers will compare the diagnostic performance of AI-assisted Fecal Microbiome Testing with colonoscopy to see the correlation between the results of both interventions.
Detailed Description: Colon cancer, also known as colorectal cancer, is the third most commonly diagnosed cancer worldwide and the second leading cause of cancer deaths. In the United States alone, it is estimated that there will be approximately 149,500 new cases and 52,980 deaths from colorectal cancer in 2021. However, if detected early, it is highly treatable and curable. Currently, the gold standard for colon cancer screening is a colonoscopy, which involves the insertion of a flexible tube with a camera into the rectum to examine the colon for signs of cancer or precancerous growths called polyps. While effective, this procedure is invasive, uncomfortable, and can be costly. As a result, many people delay or avoid colon cancer screening, which can lead to delayed detection and worse outcomes. Fecal microbiome testing is a promising alternative to colonoscopy as a screening tool for colon cancer. The human gut is home to trillions of bacteria that play a critical role in maintaining our health, and research has shown that changes in the gut microbiome can be associated with the development of colon cancer. Artificial Intelligence-assisted fecal microbiome testing involves analyzing the composition of the gut microbiome using advanced algorithms and machine learning techniques to identify patterns that are indicative of colon cancer. This non-invasive, low-cost, and convenient screening test has the potential to significantly increase colon cancer screening rates and reduce the number of deaths from this disease. By identifying individuals at high risk of colon cancer at an early stage, Artificial Intelligence-assisted fecal microbiome testing can lead to earlier intervention and better outcomes. Therefore, the diagnostic potential of AI-assisted fecal microbiome testing for colon cancer is a highly relevant and important area of research.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medipol University Esenler Hospital, Istanbul, Other (Non U.s.), Turkey
Name: Varol TUNALI, Dr.
Affiliation: Celal Bayar University Faculty of Medicine Parasitology Department
Role: PRINCIPAL_INVESTIGATOR