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Trial Title:
Evaluation of the Diagnostic Potential of Artificial Intelligence-assisted Fecal Microbiome Testing for Colon Cancer
NCT ID:
NCT05795725
Condition:
Colon Cancer
Microbiota
Colonoscopy
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
Microbiome
Colon cancer
Colonoscopy
Artificial intelligence
Screening test
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Fecal samples will be obtained from patients who are enrolled for colonoscopy for the
clinical suspicion of colon cancer
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Masking description:
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
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Artificial Intelligence-assisted Fecal Microbiome Testing
Description:
Next-generation sequencing of fecal samples and artificial intelligence analysis of test
results
Arm group label:
Colonoscopy
Intervention type:
Procedure
Intervention name:
Colonoscopy
Description:
Colonoscopy procedure
Arm group label:
Colonoscopy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- over 18 years not pregnant not meeting any of the exclusion criteria Voluntary
consent form signer * Indications for colonoscopy:
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
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Medipol University Esenler Hospital
Address:
City:
Istanbul
Zip:
34230
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Naciye Cigdem Arslan, MD
Phone:
05313890975
Investigator:
Last name:
Naciye Cigdem Arslan
Email:
Principal Investigator
Start date:
May 1, 2023
Completion date:
May 31, 2024
Lead sponsor:
Agency:
Istanbul Medipol University Hospital
Agency class:
Other
Collaborator:
Agency:
Bozyaka Training and Research Hospital
Agency class:
Other
Collaborator:
Agency:
Tepecik Training and Research Hospital
Agency class:
Other
Collaborator:
Agency:
SB Istanbul Education and Research Hospital
Agency class:
Other
Collaborator:
Agency:
Bursa City Hospital
Agency class:
Other
Collaborator:
Agency:
Izmir Metropolitan Municipality Esrefpasa Hospital
Agency class:
Other
Source:
Istanbul Medipol University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05795725
