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NCT Number: NCT06950996

A Clinical Evaluation of AI Solutions Developed in the CHAIMELEON Project for Cancer: Prostate, Lung, Breast, Colon and Rectum

The goal of this observational study is to see how useful an experimental viewer and AI solutions are for clinicians in their daily work. The investigators want to find out if the AI helps clinicians interpret medical images for different types of cancer.

The AI solutions aim to:

* Classify whether prostate cancer is low or high risk * Classify the histological subtype in breast cancer * Estimate the life expectancy of patients with lung cancer * Determine the size of colon cancer, lymph node involvement and the possibility of metastasis.. * Assess the invasion of sorrounding tissues in the case of rectum cancer. The study will involve clinicians from various centres who will review a set of cases not previously analysed by the AI. Clinicians will do this in two phases: first using only their own expertise and then with the help of the AI solutions.

The technical team want to see if the AI solutions assist clinicians and could become useful in the everyday clinical practice. Clinicians will complete a survey to share their feedback on the usability of the platform and how helpful the AI solutions are.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Lung Cancer, Non-small Cell Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Rectum Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario y Politécnico la Fe

Valencia, 46026, Spain

About this study

In order to conduct a robust clinical validation, the investigators have designed a study on the required sample size. The study is design to evaluate the role of an AI-assisted tool as a support for improving the daily clinical work. The investigators used an online website (https://statulator.com/SampleSize/ss2PP.html) for the calculation and use the "paired binary proportions" option. Using the case of prostate cancer, the investigators want to compare the probability of correct risk classification in prostate cancer by clinicians alone and/or guided by AI. The study will have a significance (α) = 0.05; power (β) = 80%; the analysis will be "two sided" and with equal group sizes.

An 10% improvement in cancer risk classification was observed when clinicians had access to an AI tool solution (Yilmaz et al.,). In addition, the authors reported that expert readers had an accuracy rate of 81% compared to 69% for novice readers when determining the Gleason score of lesions (a medical term used in pathology to classify the aggressiveness of cells in a tumour). The authors also assumed an 80% correlation between paired observations.

As a result, at least 60 new cases would be needed to evaluate the performance of the AI tool.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with an histological confirmation of cancer diagnosis (prostate, lung, breast, colon or rectum)
  • availability of radiological images (MR for prostate and rectum, CT for lung and colon or mammographys for breast).
  • enough follow up (12 months for prostate, breast and rectum), 18 months for lung, and 24 months for colon.

Exclusion criteria

  • patients with incomplete or low quality data (radiological, pathological or uncomplete clinical data necessary for the ground truth)

Treatment and study plan

Risk in prostate cancer

Other

the prediction involves the classification of the prostate cancer according to the level of prostatic antigen (PSA), the biopsy classification of the aggressiveness of the tumour, and also the localisation of the tumour

Life expectancy in lung cancer

Other

Clinicians will evaluate life expectancy in lung cancer using CTs, together with some clinical information.

Histological subtype

Other

An assessment by pathology of the subtype of breast tumour

Staging of colon cancer

Other

classify size, lymph node involvement and possibility of metastasis in medical images (computerized tomosynthesis) of thorax and pelvis region

invasion in rectum cancer

Other

assess whether vascular extramural o mesorectal fascia has been invaded in the tumour using magnetic resonance medical images taken at diagnosis in the pelvic region

Primary outcomes

  1. Usability of experimental viewer with AI tools

    Time frame: 5 months

    Usability of the platform was assessed at the end of each of the two study phases: a standard clinical phase (without artificial intelligence assistance) and a second phase assisted by AI models. Participants evaluated their experience using a 5-point Likert scale, where 1 indicated "strongly disagree" and 5 indicated "strongly agree," in response to statements regarding ease of use, interface clarity, system efficiency, overall satisfaction, and other aspects related to user interaction with the platform.

    This assessment enabled a comparison of user perceptions of the viewer's usability under both conventional clinical conditions and AI-assisted conditions. Higher scores reflect a better user experience.

  2. Utility of experimental medical images viewer

    Time frame: 5 months

    The utility of the experimental viewer was assessed by comparing clinicians' diagnostic accuracy and time spent when using the system alone versus with AI assistance. Higher accuracy and reduced interpretation time were considered indicators of greater utility. The goal was to determine whether the viewer enhances clinical decision-making, streamlines workflows, and supports better patient care.

    Additional data such as clinician gender, specialty, and experience were collected to enable subgroup analyses. Statistical evaluations included confusion matrices to assess diagnostic performance, and Sankey flow diagrams to visualize changes in decision-making between unaided and AI-assisted phases. These tools provided a comprehensive understanding of the viewer's practical benefit in real clinical scenarios.

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Collaborators

  • Centro Hospitalar do Porto
  • Charite University, Berlin, Germany
  • Hospitales Universitarios Virgen del Rocío
  • IRCCS Policlinico S. Donato
  • Istanbul Medipol University Hospital
  • Le Collège des Enseignants de Radiologie de France
  • National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
  • Osakidetza
  • University Hospital Rijeka
  • University of Messina
  • University of Pisa

Registry information

Official study title

An in Silico External Clinical Validation of AI Solutions for Cancer Management in the CHAIMELEON Project. Applied to 4 Target Types of Cancer (Lung, Breast, Prostate and Colorectal), Collected Through the Routine Delivery of Health Care With no Enrolment Conditinos (Real World Data).

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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