AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment (FECAL-AI)
28 juli 2026 bijgewerkt door: Servicio de Salud Metropolitano Sur Oriente
FECAL-AI: Prospective Observational Validation of AI-Based Stool Image Analysis Against Quantitative Fecal Immunochemical Testing for Colorectal Neoplasia Risk Assessment
This prospective observational substudy evaluates the association between artificial intelligence-derived features from stool images analyzed using the FAEX Health digital platform and fecal immunochemical test results in adults undergoing colorectal cancer screening or diagnostic evaluation.
Participants will capture stool images using a mobile application.
The primary analysis will compare AI-derived image outputs with quantitative FIT values and FIT positivity.
Secondary exploratory analyses will assess associations with colonoscopy and histopathological findings when these results are available.
The platform will be used exclusively for research and will not provide diagnoses, replace clinical evaluation, or influence medical decisions.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is a substudy of the project "Estrategia de prevención secundaria de cáncer colorrectal en personas mayores a 18 años." The substudy evaluates the FAEX Health digital platform, which applies artificial intelligence algorithms to stool images for non-diagnostic research and validation.
Participants will capture images of their stools using the FAEX Health mobile application. The images will be coded and analyzed using computational algorithms designed to identify visual characteristics such as color, consistency, and possible visible blood.
The primary objective is to evaluate the association and discriminatory performance of AI-derived stool image features for quantitative fecal immunochemical test results and FIT positivity. Secondary exploratory objectives are to assess associations between these image features and colonoscopic and histopathological findings among participants for whom these results are available.
The AI-derived results will not be returned to participants or treating clinicians and will not be used to determine whether colonoscopy or any other clinical procedure is performed. The findings may inform future studies evaluating stool image analysis as a potential triage strategy when FIT is unavailable or declined; however, the present study does not evaluate the platform as a replacement for FIT.
Personal identifiers will not be stored together with stool images. Access to coded study information will be restricted to authorized researchers, and study data will be managed according to applicable ethical, legal, and confidentiality requirements.
Studietype
Observationeel
Inschrijving (Geschat)
250
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Erik Manriquez Alegria, MD
- Telefoonnummer: +56988232111
- E-mail: erik.manriquez.alegria@gmail.com
Studie Contact Back-up
- Naam: Felipe Quezada Diaz, MD
- Telefoonnummer: +56934651992
- E-mail: ffquezad@gmail.com
Studie Locaties
-
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chili, 8207257
- Werving
- Hospital Sotero Del Rio
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Contact:
- Erik Manriquez Alegria, MD
- Telefoonnummer: +56988232111
- E-mail: erik.manriquez.alegria@gmail.com
-
Contact:
- Felipe Quezada Diaz, MD
- Telefoonnummer: +56934651992
- E-mail: ffquezad@gmail.com
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
NVT
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Adults receiving care at Hospital Dr. Sótero del Río who are undergoing colorectal cancer screening or diagnostic evaluation and have a quantitative fecal immunochemical test planned or completed.
Eligible participants will prospectively submit stool images through the FAEX Health mobile application.
AI-derived image features will be compared primarily with matched quantitative FIT results and FIT positivity.
Colonoscopy and histopathology findings will be evaluated as secondary exploratory outcomes when available.
AI results will not be returned to participants or clinicians and will not influence clinical management.
Beschrijving
Inclusion Criteria:
- Age 18 years or older.
- Referred for screening or diagnostic colonoscopy at Hospital Dr. Sótero del Río.
- Quantitative fecal immunochemical testing planned or completed within 30 days before or after stool image submission.
- Able to submit at least one stool image using the FAEX Health mobile application, independently or with assistance.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Unable or unwilling to provide written informed consent.
- Previous enrollment in the study.
- Unable to complete stool-image capture, even with assistance.
- Study images and clinical data cannot be reliably linked using the assigned study code.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Prospective Stool Image, FIT and Colonoscopy Cohort
Adults participating in colorectal cancer screening or diagnostic evaluation who submit stool images through the FAEX Health mobile application.
AI-derived stool image outputs will be compared primarily with quantitative fecal immunochemical test results and FIT positivity.
Colonoscopy and histopathology findings will be evaluated as secondary exploratory outcomes when available.
AI-derived results will not be returned to participants or clinicians and will not influence clinical decisions.
|
Participants capture stool images using the FAEX Health mobile application.
Coded images are analyzed using artificial intelligence algorithms to derive visual features and a prespecified patient-level output or score.
The AI-derived output is used exclusively for research and is compared primarily with quantitative FIT results and FIT positivity, with secondary comparisons against colonoscopy and histopathology when available.
The output is not used to provide a diagnosis or guide clinical management.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Correlation Between AI-Derived Stool Image Score and Quantitative FIT (faecal immunochemical test) Concentration
Tijdsspanne: Within 90 days of stool image submission
|
Correlation coefficient between the prespecified patient-level AI-derived stool image score and quantitative fecal immunochemical test concentration among participants with analyzable matched data, reported with a 95% confidence interval.
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Within 90 days of stool image submission
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Area Under the ROC Curve for FIT Positivity
Tijdsspanne: Within 90 days of stool image submission
|
Area under the receiver operating characteristic curve of the prespecified AI-derived stool image score for classifying participants as FIT positive or FIT negative according to the locally established FIT threshold, reported with a 95% confidence interval.
|
Within 90 days of stool image submission
|
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Sensitivity and Specificity of the AI-Derived Stool Image Score for FIT Positivity/Negativity
Tijdsspanne: Within 90 days of stool image submission
|
Sensitivity and Specificity of a prespecified AI-derived stool image score threshold for identifying participants with a positive/negative FIT result, reported as a percentage with a 95% confidence interval.
|
Within 90 days of stool image submission
|
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Area Under the ROC Curve for Colonoscopy-Detected Colorectal Neoplasia
Tijdsspanne: Within 90 days of stool image submission
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Area under the receiver operating characteristic curve of the AI-derived stool image score for identifying colorectal neoplasia detected at colonoscopy, with histopathological confirmation when available.
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Within 90 days of stool image submission
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Erik Manriquez Alegria, MD, Hospital Sotero Del Rio
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Collins GS, Moons KGM, Dhiman P, Riley RD, Beam AL, Van Calster B, Ghassemi M, Liu X, Reitsma JB, van Smeden M, Boulesteix AL, Camaradou JC, Celi LA, Denaxas S, Denniston AK, Glocker B, Golub RM, Harvey H, Heinze G, Hoffman MM, Kengne AP, Lam E, Lee N, Loder EW, Maier-Hein L, Mateen BA, McCradden MD, Oakden-Rayner L, Ordish J, Parnell R, Rose S, Singh K, Wynants L, Logullo P. TRIPOD+AI statement: updated guidance for reporting clinical prediction models that use regression or machine learning methods. BMJ. 2024 Apr 16;385:e078378. doi: 10.1136/bmj-2023-078378.
- Lee JW, Woo D, Kim KO, Kim ES, Kim SK, Lee HS, Kang B, Lee YJ, Kim J, Jang BI, Kim EY, Jo HH, Chung YJ, Ryu H, Park SK, Park DI, Yu H, Jeong S; IBD Research Group of KASID and Crohn's and Colitis Association in Daegu-Gyeongbuk (CCAiD). Deep Learning Model Using Stool Pictures for Predicting Endoscopic Mucosal Inflammation in Patients With Ulcerative Colitis. Am J Gastroenterol. 2025 Jan 1;120(1):213-224. doi: 10.14309/ajg.0000000000002978. Epub 2024 Jul 25.
- Sounderajah V, Guni A, Liu X, Collins GS, Karthikesalingam A, Markar SR, Golub RM, Denniston AK, Shetty S, Moher D, Bossuyt PM, Darzi A, Ashrafian H; STARD-AI Steering Committee. The STARD-AI reporting guideline for diagnostic accuracy studies using artificial intelligence. Nat Med. 2025 Oct;31(10):3283-3289. doi: 10.1038/s41591-025-03953-8. Epub 2025 Sep 15.
- Zhong H, Hou C, Huang Z, Chen X, Zou Y, Zhang H, Wang T, Wang L, Huang X, Xiang Y, Zhong M, Hu M, Xiong D, Wang L, Zhang Y, Luo Y, Guan Y, Xia M, Liu X, Yang J, Gan T, Wei W, Chen H, Gong H. A clinical pilot trial of an artificial intelligence-driven smart phone application of bowel preparation for colonoscopy: a randomized clinical trial. Scand J Gastroenterol. 2025 Jan;60(1):116-121. doi: 10.1080/00365521.2024.2443520. Epub 2024 Dec 22.
- Ramprasad C, Saini D, Del Carmen H, Krasnovsky L, Chandra R, Mcgregor R, Shinohara RT, Eaton E, Gummadi M, Mehta S, Lewis JD. Text Message System for the Prediction of Colonoscopy Bowel Preparation Adequacy Before Colonoscopy: An Artificial Intelligence Image Classification Algorithm Based on Images of Stool Output. Gastro Hep Adv. 2024 Sep 19;4(2):100556. doi: 10.1016/j.gastha.2024.09.011. eCollection 2025.
- Katsoula A, Paschos P, Haidich AB, Tsapas A, Giouleme O. Diagnostic Accuracy of Fecal Immunochemical Test in Patients at Increased Risk for Colorectal Cancer: A Meta-analysis. JAMA Intern Med. 2017 Aug 1;177(8):1110-1118. doi: 10.1001/jamainternmed.2017.2309.
- Rahman F, Trivedy M, Rao C, Akinlade F, Mansuri A, Aggarwal A, Laskaratos FM, Rajendran N, Banerjee S. Faecal Immunochemical Testing to Detect Colorectal Cancer in Symptomatic Patients: A Diagnostic Accuracy Study. Diagnostics (Basel). 2023 Jul 10;13(14):2332. doi: 10.3390/diagnostics13142332.
- Bailey JA, Weller J, Chapman CJ, Ford A, Hardy K, Oliver S, Morling JR, Simpson JA, Humes DJ, Banerjea A. Faecal immunochemical testing and blood tests for prioritization of urgent colorectal cancer referrals in symptomatic patients: a 2-year evaluation. BJS Open. 2021 Mar 5;5(2):zraa056. doi: 10.1093/bjsopen/zraa056.
- D'Souza N, Georgiou Delisle T, Chen M, Benton S, Abulafi M; NICE FIT Steering Group. Faecal immunochemical test is superior to symptoms in predicting pathology in patients with suspected colorectal cancer symptoms referred on a 2WW pathway: a diagnostic accuracy study. Gut. 2021 Jun;70(6):1130-1138. doi: 10.1136/gutjnl-2020-321956. Epub 2020 Oct 21.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
8 mei 2026
Primaire voltooiing (Geschat)
1 december 2026
Studie voltooiing (Geschat)
1 december 2026
Studieregistratiedata
Eerst ingediend
28 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
28 juli 2026
Eerst geplaatst (Werkelijk)
31 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
28 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HSR-FAEX-CRC-FIT-2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data will not be made publicly available or routinely shared with external researchers.
The dataset includes coded clinical information and potentially sensitive stool images, and access is restricted by participant consent, ethics approval, applicable data-protection requirements, and the research data-sharing agreement between Hospital Dr. Sótero del Río and Faex Health.
Study findings will be reported in aggregate and de-identified form.
Any future external secondary use would require separate institutional, ethical, legal, and data-sharing approvals.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .