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

NCT05795725 | Unknown DMC

• 1 other identifier: 2022-12-07
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Microbiota; Colonoscopy

Keywords

Microbiome; Colon cancer; Colonoscopy; Artificial intelligence; Screening test

Outcome Measures

Primary Outcomes (1)

• The diagnostic accuracy of the AI-assisted fecal microbiome testing in detecting colon cancer compared to colonoscopy

  The diagnostic accuracy of the AI-assisted fecal microbiome testing in detecting colon cancer, as measured by sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC-ROC).

  2 weeks

Study Arms (1)

Colonoscopy

EXPERIMENTAL

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

Diagnostic Test: Artificial Intelligence-assisted Fecal Microbiome Testing; Procedure: Colonoscopy

Interventions

Artificial Intelligence-assisted Fecal Microbiome Testing DIAGNOSTIC_TEST

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

Colonoscopy

Colonoscopy PROCEDURE

Colonoscopy procedure

Colonoscopy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Bozyaka Training and Research Hospital: collaborator
• Tepecik Training and Research Hospital: collaborator
• SB Istanbul Education and Research Hospital: collaborator
• Bursa City Hospital: collaborator
• Izmir Metropolitan Municipality Esrefpasa Hospital: collaborator

Study Sites (1)

Medipol University Esenler Hospital

Istanbul, Other (Non U.s.), 34230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Varol TUNALI, Dr.

  Celal Bayar University Faculty of Medicine Parasitology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Varol TUNALI, Dr.

CONTACT

00905556303231; varoltunali@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The patients will be blinded to the microbiome results for the study period. The gastroenterologists will be blinded to microbiome results. The microbiome researchers will be blinded to colonoscopy results The statisticians will be blinded to both intervention results until the end of patient enrollment
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Fecal samples will be obtained from patients who are enrolled for colonoscopy for the clinical suspicion of colon cancer

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 3, 2023
• Study Start: May 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: May 31, 2024
• Last Updated: April 3, 2023

Record last verified: 2023-02

Locations

TU (1)