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NCT07537491Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 17 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
910 (estimated)
First submitted
8 Apr 2026
Start date
1 Jan 2011
Primary completion date
31 Dec 2027
Lead sponsor
Rene Mantke
NCT number
NCT07537491

What you commit to

  • Study type: Observational
  • Planned participants: 910
  • From 1 Jan 2011 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients not undergoing surgical treatment

Other

  • Missing H\&E-stained tissue slides of the primary tumour
  • Histopathological material of insufficient quality for analysis

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Brandenburg an der Havel, Brandenburg an der Havel, Germany (Single-center)
Coordinator of this site? Confirm its status
Brandenburg an der HavelGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.