About this trial
The purpose of this clinical trial is to evaluate whether volatile organic compound (VOC) signatures detected in the breath of patients with cancer can serve as a potential screening tool for the early detection of cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 at the time of consent. Male and female patients to be tested.
Capable of understanding written and/or spoken English language.
Able to provide informed consent.
Cancer of any type.
Disqualifiers
Under the age of 18.
Anticipated inability to complete breath sampling procedure.
Unable to provide informed consent.
Pregnant women
Trial population
Patients diagnosed with malignancies and healthy individuals who meet the inclusion criteria.
Trial design
Cohort
Prospective
Treatments tested in this trial
Proton Transfer Reaction Mass Spectrometry Analysis
DeviceThis is a noninvasive intervention. Participants will be asked to provide a breath sample using a disposable mouthpiece equipped with a saliva/moisture trap and a non-rebreathing valve. Breath samples will be collected through normal, steady exhalation. The entire breath collection process is expected to take no more than 30 minutes to complete.
Treatment groups
Trial outcomes
Primary outcomes
VOC Signature Collection.
The successful collection of breath samples from 1000 cancer patients and 1000 healthy volunteers.
Assess the sensitivity of Machine Learning (ML) Algorithm In The Test Dataset.
Using the training dataset, qualitative output generated by the PTR-MS instrument will be analyzed using machine learning methods to identify volatile organic compound (VOC) patterns associated with different cancer types, including pancreatic, esophageal, hepatocellular carcinoma, lung, and ovarian cancers. The trained machine learning model will be tested using the dataset.
Secondary outcomes
Assess The Specificity and Accuracy of ML Analysis In The Test Dataset.
To determine the specificity, and overall diagnostic accuracy of the machine learning (ML) algorithm for detecting pancreatic, esophageal, hepatocellular carcinoma, lung, and ovarian cancers within the test dataset.
Sponsors and contacts
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