Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2025-12-24 @ 9:27 PM
NCT ID:
NCT06827132
Brief Summary:
A multinational observational study to evaluate the current pathology practices and the utilization of computational pathology plus artificial intelligence algorithms in patients with suspected lung and breast cancer.
Detailed Description:
A non-interventional study evaluating samples from patients with suspected non-small lung cancer or breast cancer to describe pathology practices and to evaluate computational pathology plus artificial intelligence algorithms in Australia, Brazil, Egypt, and Kenya. Use of digital and computational Artificial intelligence pathology in countries with low and high pathologist/population ratios is critical in developing a sustainable solution. The study has two parts, the first part will focus on breast cancer, and the second part will focus on lung cancer.
The laboratories have an active digital pathology setting and evaluate samples for cancer diagnosis. The centres of lung cancer part of the study will be selected at a later stage. The study will retrospectively evaluate samples from patients who have been preliminarily diagnosed with breast or lung cancer through clinical assessments and whose samples were evaluated only by using conventional workflow.
As part of the study, computational AI pathology algorithms will be implemented in each laboratory. Two AI pathology algorithms will be used in the breast cancer part of the study. Galen™ Breast application developed by Ibex Medical Analytics will be implemented in a laboratory in Australia. MindPeak Breast, developed by MindPeak GmbH will be implemented in laboratories in Brazil, Egypt, and Kenya. After implementing computational AI pathology algorithms, 150 samples evaluated for the primary objective from each laboratory for each cancer type will be evaluated using a conventional workflow plus an AI assisted workflow with human supervision and a conventional workflow plus an AI-assisted workflow without human supervision. These evaluations will be used to analyse secondary and exploratory objectives.
Study:
NCT06827132
Study Brief:
Protocol Section:
NCT06827132