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Staged Unimodal-to-Multimodal AI Analysis of Histopathology, CT/MRI, and Multiplex Tissue Imaging for Perioperative Risk Prediction in Colorectal Cancer (KIA-Korekt)

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Hospital Brandenburg an der Havel, Brandenburg an der Havel, Germany (Single-center)
RECRUITING
Brandenburg An Der Havel
Contact Information
Primary
Melissa Horner, MSc
melissa.schadl@mhb-fontane.de
+4915207809673
Time Frame
Start Date: 2011-01-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 910
Treatments
Group 1: Retrospective Training Cohort
Patients with colorectal cancer treated between 2011-2021 with available imaging and histopathology data.
Prospective Cohort
Patients with colorectal cancer enrolled prospectively between 2026-2028.
Related Therapeutic Areas
Sponsors
Leads: Rene Mantke
Collaborators: Technische Universität Dresden

This content was sourced from clinicaltrials.gov