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:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT07266194
Brief Summary:
Primary Objective:
1\. To evaluate the sensitivity of the SpotitEarly test for breast cancer detection in women
Secondary Objectives:
1. To evaluate the performance of the SpotitEarly in various subgroups.
2. To evaluate the performance of the SpotitEarly test in detecting early-stage cancer (stages 0-2).
3. To assess whether the performance of the SpotitEarly test is affected by psychological impacts (e.g. anxiety) related to the biopsy procedure.
Exploratory Objective:
1\. To evaluate the test-retest reliability of SpotitEarly's test.
Detailed Description:
The goal of this study is to find out whether a system that uses trained detection dogs and artificial intelligence (AI) can identify breast cancer from a person's breath. Women who are scheduled to have screening breast cancer screening, or a biopsy for a possible cancer, will be invited to take part. Participants will be asked to breathe into a surgical mask to collect a breath sample.
The mask will be sent to a special laboratory, where trained dogs and an AI-based system will check the sample for signs of breast cancer. The results from the dogs and AI will be compared to the actual results from the medical screening or biopsy to see how accurate the system is at detecting breast cancer.
Study:
NCT07266194
Study Brief:
Protocol Section:
NCT07266194