Clinical trial · Interventional
Evaluation of the Diagnostic Potential of Artificial Intelligence-assisted Fecal Microbiome Testing for Colon Cancer
Comparison of the Diagnostic Potential of Colonoscopy, and Artificial Intelligence-assisted Fecal Microbiome Testing for Colon Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colonoscopy | — | UNRESOLVED | — |
| Microbiota | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artificial Intelligence-assisted Fecal Microbiome Testing | Diagnostic Test | — | UNRESOLVED |
| Colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Colonoscopy
- description
- Fecal samples will be obtained from patients who are enrolled for colonoscopy procedures for the suspicion of colon cancer.
- interventionNames
- Diagnostic Test: Artificial Intelligence-assisted Fecal Microbiome Testing
- Procedure: Colonoscopy
Primary outcomes (1)
- measure
- The diagnostic accuracy of the AI-assisted fecal microbiome testing in detecting colon cancer compared to colonoscopy
- timeFrame
- 2 weeks
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available