Analysis of Breath Volatile Organic Compounds Using Mass Spectrometry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proton Transfer Reaction Mass Spectrometry Analysis.
- Who it may be relevant to
- Registry conditions: Pancreas Cancer, Hepatocellular Carcinoma, Lung Cancer, Ovarian Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Breath Volatile Organic Compounds (VOC) Analysis Using Proton Transfer Reaction Mass Spectrometry (PTR-MS)
Overview
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.
Detailed description
This study aims to determine whether metabolic changes associated with cancer produce distinct alterations in exhaled breath compared with those of healthy individuals. Breath samples will be analyzed using machine learning techniques to identify volatile organic compound (VOC) patterns and develop diagnostic algorithms capable of detecting multiple types of cancer. The long-term goal is to establish a noninvasive, breath-based screening tool that can facilitate the early detection of various cancers.
Additionally, patients and healthy participants who consent to this study may opt in to be contacted in the future to provide additional breath samples.
Interventions
- Device Proton Transfer Reaction Mass Spectrometry Analysis
This 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.
Primary outcome measures
- VOC Signature Collection. [Time frame: 2 Years]
- Assess the sensitivity of Machine Learning (ML) Algorithm In The Test Dataset. [Time frame: 1 Years]
Secondary outcome measures (1)
- Assess The Specificity and Accuracy of ML Analysis In The Test Dataset. [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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.
- Newly diagnosed cancer and untreated or established diagnosis of cancer. For established cancer patients, no active anti-cancer treatment for more than one month (reasons for no treatment are such as relapse, progression of cancer, refractory, or intolerance to treatment etc.)
Exclusion criteria
- Under the age of 18.
- Anticipated inability to complete breath sampling procedure.
- Unable to provide informed consent.
- Pregnant women
- Active respiratory infection symptoms
- Recent use of antibiotics
- Difficulty in performing coached exhalation
- Individuals who are unable to follow the instructions
- Cancer patients who are on active treatment for cancer or have received cancer treatment within one month
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- OU Health Stephenson Cancer Center — Oklahoma City
Identifiers
NCT: NCT07732686 · OU-SCC-VOC