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Not yet recruiting NCT07406958

Advanced Classification of Colon Tumors From CT Scans Using Deep Learning for Optimized Treatment Decision-making.

Observational Colonic Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colonic Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Advanced Classification of Colon Tumors From CT Scans Using Deep Learning for Optimized Treatment Decision-making : a Multicenter Study

Overview

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

Detailed description

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.

Primary outcome measures

  • Diagnostic performance of CT-based deep learning models for T (T1-2 vs T3-4) and N (N- vs N+) staging. [Time frame: Index preoperative CT through postoperative pathology report (within 90 days of surgery).]
Secondary outcome measures (3)
  • Detection performance for T4 tumors on preoperative CT. [Time frame: Index CT to pathology confirmation (≤90 days post-surgery).]
  • Multiclass T-stage classification accuracy (T1, T2, T3, T4). [Time frame: Index CT to pathology confirmation (≤90 days).]
  • Prognostic value of CT-derived model features for clinical outcomes and survival. [Time frame: From index CT to last follow-up (up to 5 years, or maximum available follow-up in EHR).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Departement of radiology, saint Antoin Hospital — Paris

Identifiers

NCT: NCT07406958 · APHP251408

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗