Colon CancerNCT05795725
Evaluation of the Diagnostic Potential of Artificial Intelligence-assisted Fecal Microbiome Testing for Colon Cancer
A study testing Artificial Intelligence-assisted Fecal Microbiome Testing and Colonoscopy in people with Colon Cancer and Microbiota, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colon Cancer, Microbiota, Colonoscopy
- What is being tested?
- Artificial Intelligence-assisted Fecal Microbiome Testing and Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medipol University Esenler Hospital
Istanbul, Other (Non U.s.), 34230
Naciye Cigdem Arslan, MD, 05313890975
Naciye Cigdem Arslan
About this study
Official title: Comparison of the Diagnostic Potential of Colonoscopy, and Artificial Intelligence-assisted Fecal Microbiome Testing for Colon Cancer
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.
Read the 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
- Being tested
- Artificial Intelligence-assisted Fecal Microbiome Testing, Colonoscopy
- Keywords
- Microbiome, Colon cancer, Colonoscopy, Artificial intelligence, Screening test
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-assisted Fecal Microbiome TestingDiagnostic test
Next-generation sequencing of fecal samples and artificial intelligence analysis of test results
ColonoscopyProcedure or surgery
Colonoscopy procedure
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy | Experimental | Fecal samples will be obtained from patients who are enrolled for colonoscopy procedures for the suspicion of colon cancer. Receives: Diagnostic Test: Artificial Intelligence-assisted Fecal Microbiome Testing; Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion29 Feb 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fecal samples will be obtained from patients who are enrolled for colonoscopy for the clinical suspicion of colon cancer
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bozyaka Training and Research Hospital, Tepecik Training and Research Hospital, SB Istanbul Education and Research Hospital, Bursa City Hospital, Izmir Metropolitan Municipality Esrefpasa Hospital
- Responsible party
- Sponsor
- Investigators
- Varol TUNALI, Dr., Principal investigator, Celal Bayar University Faculty of Medicine Parasitology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795725
- Sponsor's protocol ID
- 2022-12-07
- Status last verified
- Feb 2023
- First submitted
- 6 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Diagnostic Potential of Colonoscopy, and Artificial Intelligence-assisted Fecal Microbiome Testing for Colon Cancer
- ClinicalTrials.gov ID
- NCT05795725
- Acronym / sponsor ID
- 2022-12-07
- Conditions
- Colon Cancer, Microbiota, Colonoscopy
- Keywords
- Microbiome, Colon cancer, Colonoscopy, Artificial intelligence, Screening test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Bozyaka Training and Research Hospital, Tepecik Training and Research Hospital, SB Istanbul Education and Research Hospital, Bursa City Hospital, Izmir Metropolitan Municipality Esrefpasa Hospital
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fecal samples will be obtained from patients who are enrolled for colonoscopy for the clinical suspicion of colon cancer
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy | Experimental | Diagnostic Test: Artificial Intelligence-assisted Fecal Microbiome Testing, Procedure: ColonoscopyFecal samples will be obtained from patients who are enrolled for colonoscopy procedures for the suspicion of colon cancer. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Intelligence-assisted Fecal Microbiome TestingNext-generation sequencing of fecal samples and artificial intelligence analysis of test results | Diagnostic test | Colonoscopy |
| ColonoscopyColonoscopy procedure | Procedure or surgery | Colonoscopy |
Primary outcome
The diagnostic accuracy of the AI-assisted fecal microbiome testing in detecting colon cancer compared to colonoscopy
Time frame: 2 weeks
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varol TUNALI, Dr. principal investigator
Celal Bayar University Faculty of Medicine Parasitology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence-assisted Fecal Microbiome Testing and Colonoscopy in people with Colon Cancer and Microbiota, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Varol TUNALI, Dr. (00905556303231, varoltunali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic accuracy of the AI-assisted fecal microbiome testing in detecting colon cancer compared to colonoscopy (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.