Esophageal CancerNCT06453993
Temporal Variation in Exhaled Volatile Organic Compounds in Esophageal Cancer Patients
A study testing Exhaled VOC breath test in people with Esophageal Cancer, run by Benaroya Research Institute at 2 sites in 2 countries.
Trial summary
The purpose of this study is to investigate whether exhaled breath can be used to detect and monitor esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Exhaled VOC breath test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2019to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-90 years
- Newly-diagnosed, treatment naïve patients with esophageal and/or gastroesophageal junctional cancer
- Planning to undergo curative treatment, including neoadjuvant chemoradiotherapy and surgical resection
Who cannot join
- Pregnant females
- Without malignant esophageal disease
- Malignancy at a secondary site other than the esophagus
- Undergoing palliative treatment for esophageal cancer
- Not receiving neoadjuvant chemoradiotherapy and surgical resection for esophageal cancer
- Inability or unwillingness to provide written informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: Temporal Variation in Exhaled Volatile Organic Compounds in Response to Therapeutic Intervention in Esophageal Cancer Patients
The purpose of this study is to investigate whether exhaled breath can be used to detect and monitor esophageal cancer.
Read the detailed description
Esophageal cancer ("EG cancer") affects over half a millions people worldwide every year. Early esophageal cancer typically has non-specific symptoms that are often mistaken for benign (non-cancer) conditions. As a result, patients are often referred for further investigations only when they have more prominent symptoms that are typically associated with advanced incurable disease. As a consequence, 7 out of 10 new cases of EG cancer diagnosed are considered to be at an advanced stage, with less than 1 in 3 patients eligible for potentially curative therapy. Better ways of diagnosing esophageal cancer earlier are therefore needed. An ideal test for esophageal cancer would be non-invasive, simple to administer in the community, and cost effective.
The investigators' approach to this clinical challenge is to establish a non-invasive test for the detection of esophageal cancer that is based upon the unique signature of small molecules within exhaled breath. In this study that is being conducted in collaboration with researchers in the United Kingdom (UK), the investigators would like to measure the levels of these small molecules within the breath of patients with esophageal cancer at different times during their treatment: (i) at diagnosis; (ii) after chemoradiotherapy, and; (iii) after surgery. By studying how the small molecules contained within the breath change as a result of esophageal cancer and its treatment, the investigators hope to learn new information that can help develop a new test for this disease.
The investigators will also measure the small molecules within saliva and urine samples collected at the same time as breath in order to study if there are any important differences between these three samples. The investigators will also attempt to measure different bacteria
- Conditions
- Esophageal Cancer
- Being tested
- Exhaled VOC breath test
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaled VOC breath testOther
To determine longitudinal variation in exhaled VOC concentrations during intended curative therapy for EC cancer.
| Study group | Role | What they receive |
|---|---|---|
| Investigate whether exhaled breath can be used to detect and monitor esophageal cancer. | Other | The procedures will include collecting participant's personal information and samples of participant's exhaled breath, urine, and saliva. Receives: Other: Exhaled VOC breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled breath and urinary VOC concentrations as biomarkers of esophageal cancer
The composition and concentration of volitile organic compounds (VOC) in exhaled breath and urinary samples will be assessed to establish a VOC signature of esophogeal cancer
Measured: Before commencing treatment for esophageal cancer
Secondary outcomes (3)
Changes in VOC concentrations that occur in response to therapeutic intervention
VOC concentrations in exhaled breath and urinary samples will be assessed longitudinally to assess how VOC concentrations change in response to therapeutic intervention
Measured: (i) Before commencing treatment for esophageal cancer, (ii) About 4 - 6 weeks after neoadjuvant therapy, (iii) About 3 - 5 days after surgical resection (but before hospital discharge), (iv) At routine follow up (6 - 12 months after surgery)
Linkage of longitudinal VOC data to predominant upper gastrointestinal bacterial species
Bacterial RNA will be extracted from saliva samples to identify bacterial composition. Bacterial composition will then be correlated with breath and urinary VOC levels
Measured: (i) Before commencing treatment for esophageal cancer, (ii) About 4 - 6 weeks after neoadjuvant therapy, (iii) About 3 - 5 days after surgical resection (but before hospital discharge), (iv) At routine follow up (6 - 12 months after surgery)
Patient acceptability of breath test
Study subjects will be asked to complete a short survey designed to assess their understanding and opinions regarding breath testing
Measured: Before commencing treatment for esophogeal cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Dec 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Donald E Low, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453993
- Sponsor's protocol ID
- CRP19015
- Status last verified
- Aug 2024
- First submitted
- 11 Mar 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not required for analysis. Study ID used to represent study participants.
Publications
Kamal F, Kumar S, Edwards MR, Veselkov K, Belluomo I, Kebadze T, Romano A, Trujillo-Torralbo MB, Shahridan Faiez T, Walton R, Ritchie AI, Wiseman DJ, Laponogov I, Donaldson G, Wedzicha JA, Johnston SL, Singanayagam A, Hanna GB. Virus-induced Volatile Organic Compounds Are Detectable in Exhaled Breath during Pulmonary Infection. Am J Respir Crit Care Med. 2021 Nov 1;204(9):1075-1085. doi: 10.1164/rccm.202103-0660OC.
PubMed 34319857Antonowicz S, Bodai Z, Wiggins T, Markar SR, Boshier PR, Goh YM, Adam ME, Lu H, Kudo H, Rosini F, Goldin R, Moralli D, Green CM, Peters CJ, Habib N, Gabra H, Fitzgerald RC, Takats Z, Hanna GB. Endogenous aldehyde accumulation generates genotoxicity and exhaled biomarkers in esophageal adenocarcinoma. Nat Commun. 2021 Mar 5;12(1):1454. doi: 10.1038/s41467-021-21800-5.
PubMed 33674602
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Variation in Exhaled Volatile Organic Compounds in Response to Therapeutic Intervention in Esophageal Cancer Patients
- ClinicalTrials.gov ID
- NCT06453993
- Acronym / sponsor ID
- CRP19015
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 12 Jun 2024 (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 study is to investigate whether exhaled breath can be used to detect and monitor esophageal cancer.
Detailed description
Esophageal cancer ("EG cancer") affects over half a millions people worldwide every year. Early esophageal cancer typically has non-specific symptoms that are often mistaken for benign (non-cancer) conditions. As a result, patients are often referred for further investigations only when they have more prominent symptoms that are typically associated with advanced incurable disease. As a consequence, 7 out of 10 new cases of EG cancer diagnosed are considered to be at an advanced stage, with less than 1 in 3 patients eligible for potentially curative therapy. Better ways of diagnosing esophageal cancer earlier are therefore needed. An ideal test for esophageal cancer would be non-invasive, simple to administer in the community, and cost effective.
The investigators' approach to this clinical challenge is to establish a non-invasive test for the detection of esophageal cancer that is based upon the unique signature of small molecules within exhaled breath. In this study that is being conducted in collaboration with researchers in the United Kingdom (UK), the investigators would like to measure the levels of these small molecules within the breath of patients with esophageal cancer at different times during their treatment: (i) at diagnosis; (ii) after chemoradiotherapy, and; (iii) after surgery. By studying how the small molecules contained within the breath change as a result of esophageal cancer and its treatment, the investigators hope to learn new information that can help develop a new test for this disease.
The investigators will also measure the small molecules within saliva and urine samples collected at the same time as breath in order to study if there are any important differences between these three samples. The investigators will also attempt to measure different bacteria
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigate whether exhaled breath can be used to detect and monitor esophageal cancer. | Other | Other: Exhaled VOC breath testThe procedures will include collecting participant's personal information and samples of participant's exhaled breath, urine, and saliva. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-90 years
- Newly-diagnosed, treatment naïve patients with esophageal and/or gastroesophageal junctional cancer
- Planning to undergo curative treatment, including neoadjuvant chemoradiotherapy and surgical resection
Key exclusion criteria (6 listed)
- Pregnant females
- Without malignant esophageal disease
- Malignancy at a secondary site other than the esophagus
- Undergoing palliative treatment for esophageal cancer
- Not receiving neoadjuvant chemoradiotherapy and surgical resection for esophageal cancer
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 |
|---|---|---|
| Exhaled VOC breath testTo determine longitudinal variation in exhaled VOC concentrations during intended curative therapy for EC cancer. | Other | Investigate whether exhaled breath can be used to detect and monitor esophageal cancer. |
Primary outcome
Exhaled breath and urinary VOC concentrations as biomarkers of esophageal cancer
Time frame: Before commencing treatment for esophageal cancer
The composition and concentration of volitile organic compounds (VOC) in exhaled breath and urinary samples will be assessed to establish a VOC signature of esophogeal cancer
3 secondary outcomes
Changes in VOC concentrations that occur in response to therapeutic intervention
Time frame: (i) Before commencing treatment for esophageal cancer, (ii) About 4 - 6 weeks after neoadjuvant therapy, (iii) About 3 - 5 days after surgical resection (but before hospital discharge), (iv) At routine follow up (6 - 12 months after surgery)
Linkage of longitudinal VOC data to predominant upper gastrointestinal bacterial species
Time frame: (i) Before commencing treatment for esophageal cancer, (ii) About 4 - 6 weeks after neoadjuvant therapy, (iii) About 3 - 5 days after surgical resection (but before hospital discharge), (iv) At routine follow up (6 - 12 months after surgery)
Patient acceptability of breath test
Time frame: Before commencing treatment for esophogeal cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Results publication: PubMed 34319857Kamal F, Kumar S, Edwards MR, Veselkov K, Belluomo I, Kebadze T, Romano A, Trujillo-Torralbo MB, Shahridan Faiez T, Walton R, Ritchie AI, Wiseman DJ, Laponogov I, Donaldson G, Wedzicha JA, Johnston SL, Singanayagam A, Hanna GB. Virus-induced Volatile Organic Compounds Are Detectable in Exhaled Breath during Pulmonary Infection. Am J Respir Crit Care Med. 2021 Nov 1;204(9):1075-1085. doi: 10.1164/rccm.202103-0660OC.
- Results publication: PubMed 33674602Antonowicz S, Bodai Z, Wiggins T, Markar SR, Boshier PR, Goh YM, Adam ME, Lu H, Kudo H, Rosini F, Goldin R, Moralli D, Green CM, Peters CJ, Habib N, Gabra H, Fitzgerald RC, Takats Z, Hanna GB. Endogenous aldehyde accumulation generates genotoxicity and exhaled biomarkers in esophageal adenocarcinoma. Nat Commun. 2021 Mar 5;12(1):1454. doi: 10.1038/s41467-021-21800-5.
- Individual participant dataSharing planned: No. IPD is not required for analysis. Study ID used to represent study participants.
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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. This study is not recruiting at the moment.
Donald E Low, MD principal investigator
Virginia Mason Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exhaled VOC breath test in people with Esophageal Cancer, run by Benaroya Research Institute at 2 sites in 2 countries.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled breath and urinary VOC concentrations as biomarkers of esophageal cancer (time frame: Before commencing treatment for esophageal cancer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06453993, which also lists 2 linked publications.
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 27 Aug 2024.