Pancreas CancerNCT07732686
Analysis of Breath Volatile Organic Compounds Using Mass Spectrometry
An observational study of Pancreas Cancer and Hepatocellular Carcinoma, run by University of Oklahoma at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreas Cancer, Hepatocellular Carcinoma, Lung Cancer
- What is being tested?
- Proton Transfer Reaction Mass Spectrometry Analysis
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with malignancies and healthy individuals who meet the inclusion criteria.
Who may be able to join
- 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.)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nirmal Choradia, MD contact
United States1 site
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
Nirmal Choradia, MD, Nirmal-Choradia@ouhsc.edu
About this study
Official title: Breath Volatile Organic Compounds (VOC) Analysis Using Proton Transfer Reaction Mass Spectrometry (PTR-MS)
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.
Read the 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.
- Conditions
- Pancreas Cancer, Hepatocellular Carcinoma, Lung Cancer, Ovarian Cancer, Breast Cancer, Head and Neck Cancer
- Being tested
- Proton Transfer Reaction Mass Spectrometry Analysis
- Keywords
- VOC, PTR-MS, ML
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Hepatocellular, Lung Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, Colonic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Transfer Reaction Mass Spectrometry AnalysisDevice
Also called PTR-MS
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.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed Malignancies | Participants in this group either have a newly diagnosed, untreated cancer or a pre-existing cancer diagnosis but are not currently receiving anticancer therapy. Participants with a pre-existing diagnosis must not have received any anticancer treatment within the previous month. Receives: Device: Proton Transfer Reaction Mass Spectrometry Analysis | |
| Healthy Control Group | Participants in this control group have no current or prior diagnosis of a malignancy. Receives: Device: Proton Transfer Reaction Mass Spectrometry Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
VOC Signature Collection.
The successful collection of breath samples from 1000 cancer patients and 1000 healthy volunteers.
Measured: 2 Years
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.
Measured: 1 Years
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nirmal Choradia, MD, Principal investigator, University of Oklahoma - Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732686
- Sponsor's protocol ID
- OU-SCC-VOC
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Volatile Organic Compounds (VOC) Analysis Using Proton Transfer Reaction Mass Spectrometry (PTR-MS)
- ClinicalTrials.gov ID
- NCT07732686
- Acronym / sponsor ID
- OU-SCC-VOC
- Conditions
- Pancreas Cancer, Hepatocellular Carcinoma, Lung Cancer, Ovarian Cancer, Breast Cancer, Head and Neck Cancer
- Keywords
- VOC, PTR-MS, ML
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnosed Malignancies | – | Device: Proton Transfer Reaction Mass Spectrometry AnalysisParticipants in this group either have a newly diagnosed, untreated cancer or a pre-existing cancer diagnosis but are not currently receiving anticancer therapy. Participants with a pre-existing diagnosis must not have received any anticancer treatment within the previous month. |
| Healthy Control Group | – | Device: Proton Transfer Reaction Mass Spectrometry AnalysisParticipants in this control group have no current or prior diagnosis of a malignancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with malignancies and healthy individuals who meet the inclusion criteria.
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (9 listed)
- Under the age of 18.
- Anticipated inability to complete breath sampling procedure.
- Unable to provide informed consent.
- Pregnant women
- Active respiratory infection symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Transfer Reaction Mass Spectrometry AnalysisAlso: PTR-MSThis 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. | Device | Diagnosed Malignancies, Healthy Control Group |
Primary outcome
VOC Signature Collection.
Time frame: 2 Years
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.
Time frame: 1 Years
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.
1 secondary outcome
Assess The Specificity and Accuracy of ML Analysis In The Test Dataset.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nirmal Choradia, MD contact
Nirmal Choradia, MD principal investigator
University of Oklahoma - Stephenson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer and Hepatocellular Carcinoma, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lead Onco Nurse (405-271-8777, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VOC Signature Collection. (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.