Evaluation of the Diagnostic Potential of Artificial Intelligence-assisted Fecal Microbiome Testing for Colon Cancer

NCT ID: NCT05795725

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-05-31

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.

Conditions

Colon Cancer; Microbiota; Colonoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Colonoscopy

Fecal samples will be obtained from patients who are enrolled for colonoscopy procedures for the suspicion of colon cancer.

Group Type: EXPERIMENTAL

Artificial Intelligence-assisted Fecal Microbiome Testing

Intervention Type: DIAGNOSTIC_TEST

Next-generation sequencing of fecal samples and artificial intelligence analysis of test results

Colonoscopy

Intervention Type: PROCEDURE

Colonoscopy procedure

Interventions

Artificial Intelligence-assisted Fecal Microbiome Testing

Next-generation sequencing of fecal samples and artificial intelligence analysis of test results

Intervention Type: DIAGNOSTIC_TEST

Colonoscopy

Colonoscopy procedure

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

Colorectal cancer or adenomatous polyp in first-degree relatives Patients followed for more than 8 years with ulcerative colitis, Crohn's Disease, or individuals with a history of hereditary polyposis or non-polyposis syndrome. In these groups, the screening procedure should be started from the age of 40.

It is a population-based screening that begins at age 50 and ends at age 70 for all men and women (50 and 70 years will be included). However, especially in this group of patients;

Male patients presenting with iron deficiency anemia Female patients over 40 years of age presenting with iron deficiency anemia Patients with positive occult blood in stool in screening programs Patients presenting with rectal bleeding Patients with defecation irregularity, weight loss

• under 18 years old
• Pregnant or planning to become
• Have another known diagnosis of gastrointestinal disease
• Abdominal surgery other than appendectomy or hysterectomy history
• Psychiatric comorbidity
• Chronic diseases that will affect the microbiome (cancer, diabetes, cardiovascular disease, liver diseases, neurological diseases, etc.)
• Use of drugs that may affect digestive function (including use in the last 4 weeks), probiotics, narcotic analgesics, lactulose (prebiotics) in the 4 weeks before the study
• Patients taking dietary supplements will not be included in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bozyaka Training and Research Hospital

OTHER

Sponsor Role: collaborator

Tepecik Training and Research Hospital

OTHER

Sponsor Role: collaborator

SB Istanbul Education and Research Hospital

OTHER

Sponsor Role: collaborator

Bursa City Hospital

OTHER_GOV

Sponsor Role: collaborator

Izmir Metropolitan Municipality Esrefpasa Hospital

UNKNOWN

Sponsor Role: collaborator

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Varol TUNALI, Dr.

Role: PRINCIPAL_INVESTIGATOR

Celal Bayar University Faculty of Medicine Parasitology Department

Locations

Medipol University Esenler Hospital

Istanbul, Other (Non U.s.), Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Varol TUNALI, Dr.

Role: CONTACT

varoltunali@gmail.com

00905556303231

Facility Contacts

Naciye Cigdem Arslan, MD

Role: primary

05313890975

Other Identifiers

2022-12-07

Identifier Type: -

Identifier Source: org_study_id