The AIDPRO-CRC Trial

Launched by ZEALAND UNIVERSITY HOSPITAL · Oct 15, 2024

Keywords

ClinConnect Summary

The AIDPRO-CRC trial is a study designed to improve the care of patients undergoing surgery for colorectal cancer by using artificial intelligence (AI) to help surgeons assess the risk of complications and death. This trial will compare two groups of patients: one group will have their risk evaluated using standard methods by their surgeon, while the other group will receive AI-assisted assessments. The goal is to provide more personalized care based on each patient’s specific risk, which could lead to fewer complications and hospital readmissions.

To participate in the trial, patients must be at least 18 years old and have been diagnosed with colorectal cancer that requires surgery. They will be randomly assigned to one of the two assessment methods but will receive the same standard treatment throughout. This trial is taking place in eight hospitals across Denmark, and while it is not yet recruiting participants, those who qualify can expect close monitoring and tailored care based on their individual risk levels. Importantly, the study builds on previous successful research, suggesting that this approach could lead to better outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• To be eligible for inclusion, the patient must:
• • Have histologically confirmed clinical and/or pathological evidence of suspected first occurrence of clinical stage I to IV colorectal carcinoma.
• • Be ≥ 18 years of age on the date of signing the informed consent.
• • Provide written informed consent prior to registration according to the local regulatory requirements.
• • Have indication for elective curative intended surgery decided by the MDT-conference
• • Available information about the covariates needed for the AIDPRO manual CRC device to execute not assessed/directly evaluated by the surgeon (e.g. ASA-score and WHO-performance score) o Blood test (must not be older than 30 days from the time of inclusion): Carcinoembryonic Ag(CEA) \[Mass/volume\] in Serum or Plasma (microgram per liter) C-reactive protein (CRP) \[Mass/volume\] in Serum or Plasma (milligram per liter) Hemoglobin (Hgb) \[Moles/volume\] in Blood (millimole per liter) Bilirubin \[Moles/volume\] in Serum or Plasma (micromole per liter) Albumin \[Mass/volume\] in Serum or Plasma (gram per liter) Sodium (Na) \[Moles/volume\] in Serum or Plasma (millimole per liter) eGFR \[milliliters/minute\] mL/min/1,73 m2 calculated from Creatinin and height
• Exclusion Criteria:
• The patient may be excluded from participation in the trial if the patient:
• • Have indication for elective curative intended surgery revised and canceled in the preoperative phase.
• • Has any serious or uncontrolled medical disorder that, in the opinion of the investigator or treating physician, may increase the risk associated with study participation, impair the ability of the subject to receive protocol intervention, or interfere with the interpretation of study results.
• • Has any language and/or mental diasability imparing the ability to actively participate in perioperative interventions and the ability to answer relevant questionaries.