RecruitingOBSERVATIONAL

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

The KIA-Korekt study is looking into how powerful computer analysis, known as Artificial Intelligence (AI), can help predict problems after bowel (colorectal) cancer surgery. Many people undergoing this surgery can face complications like infections. Current ways of predicting these risks aren't always precise enough. This research uses AI to examine different types of medical information, including detailed scans of tissue samples, pre-surgery CT and MRI scans. By bringing all this information together, the study hopes to create better prediction tools. This could help doctors understand each patient's individual risks more accurately, allowing them to plan surgery and recovery care more effectively and potentially improve outcomes for patients.

At a glance

Status

Recruiting

Sponsor

Rene Mantke

Enrolment target

910

Start

01 Jan 2011

Estimated completion

30 Jun 2028

Colorectal Cancer Postoperative Complications

What is this study about?

Bowel cancer is a common condition, and surgery is a key part of treatment. While surgical techniques have improved a lot, some people can still experience complications afterwards, such as infections, problems with the surgical join in the bowel, or needing to spend time in intensive care. These complications can affect a patient's recovery, quality of life, and even their long-term health. Doctors currently use some tools to assess risk, but these don't always fully capture the unique situation of each patient.

This study, called KIA-Korekt, aims to make these predictions much more accurate by using advanced computer analysis, known as Artificial Intelligence (AI). Think of AI as a very clever computer program that can learn from large amounts of information. In this study, the AI will be 'learning' from three main types of medical information: detailed pictures of tissue samples from the tumour (like those taken under a microscope), pre-surgery CT and MRI scans, and even more detailed images of cells within the tumour.

The idea is that by combining and analysing all these different types of information, the AI can spot patterns that might tell us who is more likely to face specific difficulties after surgery. This could allow doctors to better prepare for individual patients, offering more tailored care before, during, and after their operation. The study will first look back at information from patients treated in the past and then test what it learns on new patients in the future.

Key takeaways

Uses advanced computer analysis (AI) to improve predictions of surgical complications.
Aims to make care more personalised for bowel cancer patients.
Utilises existing medical scans and tissue samples, not new procedures.
No direct impact on your current treatment plan.
Research could lead to better patient outcomes in the future.
Data privacy is a top priority; all data is anonymised.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older.

You would need to have received a confirmed diagnosis of bowel (colorectal) cancer and be planning to have surgery for it, whether it's to try and cure the cancer or to help manage symptoms.

Crucially, the study also needs to be able to get hold of tissue samples from your tumour that were taken during your diagnosis or surgery. These samples need to be of good enough quality for the special computer analysis they will be doing. If you are not having surgery, or if there aren't suitable tissue samples available, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with bowel (colorectal) cancer?
Are you having surgery for your bowel cancer?
Are suitable tumour tissue samples available from your diagnosis or surgery?

Answer every question to see your result.

What does participation involve?

This study primarily uses information and samples that are already collected as part of your standard medical care, or will be collected in the future if you join the prospective validation cohort. This means: You will not be given any new medications or treatments specially for this study. The study looks at existing medical images (like CT and MRI scans), and tissue samples (like biopsy or surgical samples) that are routinely taken as part of your cancer diagnosis and treatment. For patients joining the 'future' part of the study, this information would be collected as you go through your standard care from 2026 to 2028. There are no additional visits, assessments, or follow-up appointments required solely for this research. Your participation mainly involves allowing the research team to use your anonymised medical data and tissue samples for their analysis. The total duration of your 'participation' in terms of data contribution would cover your perioperative period and 30 days post-surgery, but without any direct involvement from you beyond your standard medical care.

Potential risks and benefits

Potential benefits of this study include contributing to a better understanding of individual risks after bowel cancer surgery, which could lead to more personalised care and improved patient outcomes in the future. There are no direct medical benefits to you as an individual. Since the study mainly uses existing, anonymised medical information and samples, the risks to you are very low. Your personal information will be protected, and the results will be used for research purposes only. You have the right to withdraw your consent for your data and samples to be used in the study at any time, without affecting your medical care.

Locations (1)

University Hospital Brandenburg an der Havel, Brandenburg an der Havel, Germany (Single-center)
Verified postcode
Brandenburg an der Havel, Germany· Recruiting

Common questions

What is AI and how is it used in this study?

AI stands for Artificial Intelligence. In this study, it's a clever computer program that learns from medical images and tissue samples to predict who might be at higher risk of complications after surgery.

Will taking part in this study change my treatment?

No, this study will not change your treatment. It uses information from your standard medical care to help improve predictions for future patients.

Do I need to have extra tests for this study?

No, you will not have any extra tests. The study uses scans and tissue samples that are already collected as part of your normal diagnosis and treatment.

How is my privacy protected?

Your personal information will be kept confidential and your data will be used anonymously for research purposes only. Your name or other identifying details will not be linked to the research findings.

What kind of complications are they looking to predict?

The study aims to predict complications like infections, problems with the surgical join, severe infections (sepsis), needing intensive care, or other issues within 30 days after surgery.

How to find out more

Melissa Horner, MSc

melissa.schadl@mhb-fontane.de +4915207809673 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.