Departement of radiology, saint Antoin Hospital
Paris, 75012, France
NCT Number: NCT07406958
This study aims to improve the classification of colon tumors using deep learning models trained on CT scans, specifically to distinguish between T1-T2 vs. T3-T4 stages and N- vs. N+ lymph node involvement. This classification is critical to guide preoperative treatment such as chemotherapy or immunotherapy. Given the limited accuracy of radiologists in current staging practice, automated image-based AI tools could enhance diagnostic precision and reproducibility, leading to more personalized and effective treatment planning. The investigator will develop and validate convolutional and transformer-based deep learning models using a large annotated dataset from multiple centers. Secondary objectives include fine-grained staging (T1 to T4), subgroup-specific models (MSS vs MSI), and predictive models for surgical
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Paris, 75012, France
This is a retrospective, non-interventional, observational study evaluating the use of deep learning methods to improve preoperative CT-based TNM staging in patients with colon cancer. The study is conducted across multiple sites within the AP-HP hospital network (Paris, France) and uses data extracted from the institutional Health Data Warehouse.
Radiologic accuracy in assessing tumor stage (T) and lymph node status (N) remains limited, despite being critical for selecting neoadjuvant treatments. Artificial intelligence models trained on annotated imaging data may provide more consistent, reproducible, and accurate classification.
The study cohort includes adult patients who underwent colon resection between January 2017 and November 2024, with a preoperative CT scan and corresponding pathology report. Eligible cases are identified using standardized diagnostic (ICD-10) and procedural (CCAM) codes. Imaging and clinical data are de-identified prior to analysis.
Several AI model architectures will be tested, including 3D convolutional neural networks and transformer-based approaches. CT scans will be pre-processed using standard pipelines; pathology labels will be extracted using natural language processing (NLP) techniques or manual review when needed. Model performance will be assessed through cross-validation and evaluated using AUC, F1-score, sensitivity, and specificity.
Exploratory analyses will include fine-grained tumor staging and the potential prognostic value of image-based features for clinical outcomes such as survival.
No study-related procedures are performed. All analyses are conducted on existing data, in compliance with French data protection and ethical regulations.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adults who underwent colon resection surgery at an AP-HP hospital between 01/01/2017 and 01/11/2024, with:
A preoperative abdominopelvic CT scan available within 60 days prior to surgery.
A corresponding pathology report (anatomopathological results) available within 90 days post-surgery.
Colon resection identified by CCAM procedure codes:
HHFA002, HHFA004, HHFA005, HHFA006, HHFA008, HHFA009, HHFA010, HHFA014, HHFA017, HHFA018, HHFA021, HHFA022, HHFA023, HHFA024, HHFA026, HHFA028, HHFA029, HHFA030, HHFA031, HHFC040, HHFC296.
Confirmed diagnosis of colon tumor by ICD-10 code:
C18* (colonic neoplasms).
Exclusion criteria
Patients who received neoadjuvant chemotherapy prior to surgery, identified by ICD-10 codes Z511 or Z512 recorded before the surgical act.
These exclusions will be refined and confirmed through manual medical record review to ensure accuracy.
Absence of usable CT imaging or anatomical pathology data linked to the surgical event.
Time frame: Index preoperative CT through postoperative pathology report (within 90 days of surgery).
Area under the ROC curve (AUC) and F1-score of deep learning models in (a) classifying early vs advanced T stage (T1-2 vs T3-4) and (b) nodal status (N- vs N+) compared with pathology gold standard. Sensitivity, specificity, PPV, NPV reported as supportive metrics; model performance compared to historical radiologist benchmarks when available.
Time frame: Index CT to pathology confirmation (≤90 days post-surgery).
AUC, F1, sensitivity, specificity for binary classification T4 vs non-T4 (T1-3). Analyses stratified by tumor location and contrast phase when data permit.
Time frame: Index CT to pathology confirmation (≤90 days).
Macro-averaged F1, per-class sensitivity/specificity, confusion matrix, and Cohen's kappa comparing model-predicted 4-class T stage with pathology.
Time frame: From index CT to last follow-up (up to 5 years, or maximum available follow-up in EHR).
Association between model outputs (probabilities, embeddings) and (a)coverall survival, (b) disease-free survival. Evaluated using Kaplan-Meier analysis, log-rank tests, and multivariable Cox models adjusted for clinical covariates where available.
Contact information is provided by the study sponsor or research team.
Mathilde WAGNER, MD,PhD
CONTACT
Quentin Vanderbecq, MD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Advanced Classification of Colon Tumors From CT Scans Using Deep Learning for Optimized Treatment Decision-making : a Multicenter Study
Acronym: DeepColScan
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00004547
Abdominal Neoplasm, Abdominal Neoplasms
Bethesda, Maryland, United States
View Trial DetailsNCT01725321
Colonic Diseases, Colonic Neoplasm
Hong Kong, China
View Trial DetailsNCT07691489
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Basking Ridge, New Jersey, United States
View Trial DetailsNCT07306390
Colon Cancer, Colonic Diseases
Beijing, China
View Trial Details