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Clinical Trials in Germany / NCT07537491
Recruiting Observational

KIA-Korekt: Staged Unimodal-to-Multimodal AI Evaluation for Perioperative Risk Prediction in Colorectal Cancer

NCT07537491 · tracked via the Priya Life Science Germany tracker
Sponsor
Rene Mantke
Phase
Observational
Started
2011-01-01
Last updated
2026-04-17

Condition(s) studied

Colorectal Cancer Postoperative Complications

Study summary

Perioperative complications following surgery for colorectal cancer (CRC) represent a major cause of postoperative morbidity and mortality. Existing risk stratification tools lack the precision to capture the complex biological and morphological factors that determine individual patient vulnerability. Artificial intelligence (AI)-based analysis of medical imaging data offers a promising approach to improve preoperative risk prediction.

The KIA-Korekt study investigates whether perioperative complications in CRC patients can be predicted using multimodal AI-based image analysis. Three complementary imaging modalities are integrated: digital histopathology (haematoxylin-eosin whole-slide images, H\&E-WSIs), preoperative CT and MRI radiomics, and multiplex tissue imaging (mTI) including multiplex immunohistochemistry (mIHC) and imaging mass cytometry (IMC).

The study includes a retrospective cohort of approximately 750 CRC patients treated between 2011 and 2021, and a prospective validation cohort of approximately 210 patients recruited from 2026 to 2028. Deep learning and radiomic feature extraction pipelines are applied to all modalities individually and in multimodal combination. Predicted outcomes include anastomotic leakage, wound infection, sepsis, ICU admission, and in-hospital mortality within 30 days of surgery.

The study is conducted at the University Hospital Brandenburg, Brandenburg Medical School Theodor Fontane, in collaboration with the Department of Computational Pathology, TU Dresden.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients (≥18 years) * Histologically confirmed colorectal adenocarcinoma * Undergoing surgical resection (curative or palliative intent) * Availability of H\&E-stained whole-slide images (WSIs) from the primary tumour Exclusion Criteria: * Patients not undergoing surgical treatment * Missing H\&E-stained tissue slides of the primary tumour * Histopathological material of insufficient quality for analysis

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital Brandenburg an der Havel, Brandenburg an der Havel, Germany (Single-center) Brandenburg an der Havel Germany Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07537491 on ClinicalTrials.gov ↗ ← All trials in Germany