Colorectal CancerVOLGACORENCT02332213
Volatile Markers in Digestive Cancer
An observational study of Colorectal Cancer and Colorectal Adenoma, run by University of Latvia at 2 sites in 2 countries.
Trial summary
The study is aimed to determine the potential of volatile marker testing for identification of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related precancerous lesions in the stomach and colon. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma, Gastric Cancer
- What is being tested?
- Breath sampling for volatile marker detection, Upper endoscopy with biopsies and Colonoscopy with biopsies or lesion removal when required
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 2,022 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2014to 30 Jun 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cancer patients (Group 1 and 5) will be predominantly enrolled at the time scheduled for surgery, however also patients undergoing diagnostic procedures (endoscopy) will be eligible Patients without malignant disease but defined colorectal (Groups 2-4) status will be predominantly enrolled prior colonoscopy in out-patient settings. Sampling starting from 1 week after colonoscopy will be allowed if the lesions will not get removed during the index endoscopy Patients without malignant disease but defined gastric mucosal status (Groups 6-8) status will be predominantly enrolled prior upper endoscopy in out-patient settings. Sampling starting from 2 days after upper endoscopy will be allowed if the lesions will not get removed during the index endoscopy Average cancer risk subjects (Group 9) will get enrolled by inviting individuals predominantly selected from the lists of general practitioners.
Who may be able to join
- Patients with verifies colorectal cancer (Group 1)
- Patients with verified gastric cancer (Group 5)
- Patients undergoing colonoscopy due to clinical indications (group 2-4)
- Patients undergoing upper endoscopy due to clinical indications (Group 6-8)
- Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 9)
- Motivation to participate in the study
- Physical status allowing volatile marker sampling and other procedures within the protocol
- Signed consent
Who cannot join
- Known other active cancer
- Ventilation problems, airway obstruction
- Unwillingness or inability to co-operate
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Volatile Marker Testing for Digestive Cancer and Precancerous Lesion Detection, Evaluation of Confounding Factors
The study is aimed to determine the potential of volatile marker testing for identification of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related precancerous lesions in the stomach and colon.
The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.
Read the detailed description
Patients with established disease (cancer, precancerous lesions) as well as patients investigated for the lesions and having been documented lack of the lesions will be enrolled to the study at clinical sites in Europe (Latvia, Lithuania). In addition, group of persons from general population at average risk for developing the target disease will be also enrolled.
Testing of volatile markers will be conducted by one of two methods: 1) gas chromatography coupled to mass spectroscopy (GS-MS) and 2) nanosensor technology.
Volunteers (including patients with established disease) will be enrolled prior the removal of the target lesion (e.g. surgery for cancer or polypectomy in the case of a polyp).
The study will be conducted by utilizing the experience of institutions in the European Union and Israel.
- Conditions
- Colorectal Cancer, Colorectal Adenoma, Gastric Cancer, Peptic Ulcer Disease, Atrophic Gastritis, Intestinal Metaplasia
- Being tested
- Breath sampling for volatile marker detection, Upper endoscopy with biopsies, Colonoscopy with biopsies or lesion removal when required, Plasma/serum sampling, Faecal sample acquisition
- Keywords
- Volatile organic compounds, Nanosensor technology, GC-MS, Breath-testing, Digestive cancer, Precancerous lesions, Colorectal cancer, Adenoma, Gastric cancer, Atrophic gastritis, OLGIM
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Peptic Ulcer, Gastritis, Atrophic, Gastrointestinal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath sampling for volatile marker detectionProcedure or surgery
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Upper endoscopy with biopsiesProcedure or surgery
Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for microbiota testing
Colonoscopy with biopsies or lesion removal when requiredProcedure or surgery
Colonoscopy with proper biopsy or polypectomy material work-up will be used for identification and stratification of colorectal lesions as well as acquisition of biopsies for microbiota testing
Plasma/serum samplingProcedure or surgery
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal sample acquisitionProcedure or surgery
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Histological evaluation of the surgery materialProcedure or surgery
The material obtained during surgery (stomach or colorectal) will be used for confirmation of the diagnosis in cancer groups. Surgery itself will be performed according to the clinical indications, and will not be extended (i.e. cannot be considered a study intervention)
| Study group | Role | What they receive |
|---|---|---|
| 1. Colorectal cancer | Patients with histologically confirmed colorectal cancer (adenocarcinoma) Receives: Procedure: Breath sampling for volatile marker detection; Procedure: Colonoscopy with biopsies or lesion removal when required; Procedure: Plasma/serum sampling; Procedure: Faecal sample acquisition; Procedure: Histological evaluation of the surgery material | |
| 2. Colorectal high-risk lesions | Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions. Receives: Procedure: Breath sampling for volatile marker detection; Procedure: Colonoscopy with biopsies or lesion removal when required; Procedure: Plasma/serum sampling; Procedure: Faecal sample acquisition | |
| 3. Colorectal low-risk adenoma | Patients without colorectal adenocarcinoma and without colorectal high-risk lesions as described under Group 2 criteria Receives: Procedure: Breath sampling for volatile marker detection; Procedure: Colonoscopy with biopsies or lesion removal when required; Procedure: Plasma/serum sampling; Procedure: Faecal sample acquisition | |
| 4. Group of control (colorectal) | Patients having undergone colonoscopy without an evidence for colorectal lesions fulfilling Group 1 or Group 2 or Group 3 criteria. Prior to removal of the lesions. Receives: Procedure: Breath sampling for volatile marker detection; Procedure: Colonoscopy with biopsies or lesion removal when required; Procedure: Plasma/serum sampling; Procedure: Faecal sample acquisition | |
| 5. Gastric cancer | Patients with histologically confirmed gastric cancer (adenocarcinoma) Receives: Procedure: Breath sampling for volatile marker detection; Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Faecal sample acquisition; Procedure: Histological evaluation of the surgery material | |
| 6. Gastric dysplasia | Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach Receives: Procedure: Breath sampling for volatile marker detection; Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Faecal sample acquisition | |
| 7. High-risk gastric lesions | Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, but excluding those with dysplasia (Group 5) Receives: Procedure: Breath sampling for volatile marker detection; Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Faecal sample acquisition | |
| 8. Normal and low-risk gastric lesions | Staged 0-III according to OLGIM. Dysplasia should be excluded Receives: Procedure: Breath sampling for volatile marker detection; Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Faecal sample acquisition | |
| 9. Average risk population | Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer. Receives: Procedure: Breath sampling for volatile marker detection; Procedure: Plasma/serum sampling; Procedure: Faecal sample acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of nanoarray sensor testing to detect target lesions
Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis
Measured: At the time of breath sampling
VOCs differentiating the study groups
List of VOCs assayed by GC-MS with statistical difference between the study groups
Measured: At the time of breath sampling
Secondary outcomes (3)
Identification of characteristic VOC pattern in risk age groups
List of characteristic VOCs in general population at risk for developing gastrointestinal cancer, including analysis of confounding factors, e.g. dietary habits, smoking, and profession.
Measured: At the time of sampling
VOC pattern changes following treatment
Significant change in VOC content before and following treatment (surgery, medical therapy, combined)
Measured: At baseline and every 6 months within 3 year period
Groups of gastrointestinal microbiota correlating to VOCs
List of gastrointestinal microbiota groups (phylum/genus level) with positive correlation to particular VOCs
Measured: At the time of sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJan 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,022 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Latvia
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology, Lithuanian University of Health Sciences, Karolinska Institutet, German Cancer Research Center, Digestive Diseases Centre GASTRO, Riga East Clinical University Hospital, Academic Histology Laboratory (Latvia), JLM Innovation GmbH (Germany)
- Responsible party
- Sponsor
- Investigators
- Hossam Haick, Ph.D., Principal investigator, Technion, Israel Institute for Technology (Israel)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332213
- Sponsor's protocol ID
- 2914
- Other IDs
- LZP Nr. 2014.10-5
- Acronym
- VOLGACORE
- Status last verified
- Aug 2018
- First submitted
- 30 Dec 2014
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Haick H, Broza YY, Mochalski P, Ruzsanyi V, Amann A. Assessment, origin, and implementation of breath volatile cancer markers. Chem Soc Rev. 2014 Mar 7;43(5):1423-49. doi: 10.1039/c3cs60329f. Epub 2013 Dec 4.
PubMed 24305596Xu ZQ, Broza YY, Ionsecu R, Tisch U, Ding L, Liu H, Song Q, Pan YY, Xiong FX, Gu KS, Sun GP, Chen ZD, Leja M, Haick H. A nanomaterial-based breath test for distinguishing gastric cancer from benign gastric conditions. Br J Cancer. 2013 Mar 5;108(4):941-50. doi: 10.1038/bjc.2013.44.
PubMed 23462808Amal H, Leja M, Broza YY, Tisch U, Funka K, Liepniece-Karele I, Skapars R, Xu ZQ, Liu H, Haick H. Geographical variation in the exhaled volatile organic compounds. J Breath Res. 2013 Dec;7(4):047102. doi: 10.1088/1752-7155/7/4/047102. Epub 2013 Nov 1.
PubMed 24184568
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatile Marker Testing for Digestive Cancer and Precancerous Lesion Detection, Evaluation of Confounding Factors
- ClinicalTrials.gov ID
- NCT02332213
- Acronym / sponsor ID
- VOLGACORE / 2914
- Conditions
- Colorectal Cancer, Colorectal Adenoma, Gastric Cancer, Peptic Ulcer Disease, Atrophic Gastritis, Intestinal Metaplasia
- Keywords
- Volatile organic compounds, Nanosensor technology, GC-MS, Breath-testing, Digestive cancer, Precancerous lesions, Colorectal cancer, Adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,022 participants (actual)
- Lead sponsor
- University of LatviaUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology, Lithuanian University of Health Sciences, Karolinska Institutet, German Cancer Research Center, Digestive Diseases Centre GASTRO, Riga East Clinical University Hospital, Academic Histology Laboratory (Latvia), JLM Innovation GmbH (Germany)
- Study start
- Jan 2014
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 6 Jan 2015 (estimated)
- 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 study is aimed to determine the potential of volatile marker testing for identification of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related precancerous lesions in the stomach and colon.
The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.
Detailed description
Patients with established disease (cancer, precancerous lesions) as well as patients investigated for the lesions and having been documented lack of the lesions will be enrolled to the study at clinical sites in Europe (Latvia, Lithuania). In addition, group of persons from general population at average risk for developing the target disease will be also enrolled.
Testing of volatile markers will be conducted by one of two methods: 1) gas chromatography coupled to mass spectroscopy (GS-MS) and 2) nanosensor technology.
Volunteers (including patients with established disease) will be enrolled prior the removal of the target lesion (e.g. surgery for cancer or polypectomy in the case of a polyp).
The study will be conducted by utilizing the experience of institutions in the European Union and Israel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1. Colorectal cancer | – | Procedure: Breath sampling for volatile marker detection, Procedure: Colonoscopy with biopsies or lesion removal when required, Procedure: Plasma/serum sampling, Procedure: Faecal sample acquisition, Procedure: Histological evaluation of the surgery materialPatients with histologically confirmed colorectal cancer (adenocarcinoma) |
| 2. Colorectal high-risk lesions | – | Procedure: Breath sampling for volatile marker detection, Procedure: Colonoscopy with biopsies or lesion removal when required, Procedure: Plasma/serum sampling, Procedure: Faecal sample acquisitionPatients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions. |
| 3. Colorectal low-risk adenoma | – | Procedure: Breath sampling for volatile marker detection, Procedure: Colonoscopy with biopsies or lesion removal when required, Procedure: Plasma/serum sampling, Procedure: Faecal sample acquisitionPatients without colorectal adenocarcinoma and without colorectal high-risk lesions as described under Group 2 criteria |
| 4. Group of control (colorectal) | – | Procedure: Breath sampling for volatile marker detection, Procedure: Colonoscopy with biopsies or lesion removal when required, Procedure: Plasma/serum sampling, Procedure: Faecal sample acquisitionPatients having undergone colonoscopy without an evidence for colorectal lesions fulfilling Group 1 or Group 2 or Group 3 criteria. Prior to removal of the lesions. |
| 5. Gastric cancer | – | Procedure: Breath sampling for volatile marker detection, Procedure: Upper endoscopy with biopsies, Procedure: Plasma/serum sampling, Procedure: Faecal sample acquisition, Procedure: Histological evaluation of the surgery materialPatients with histologically confirmed gastric cancer (adenocarcinoma) |
| 6. Gastric dysplasia | – | Procedure: Breath sampling for volatile marker detection, Procedure: Upper endoscopy with biopsies, Procedure: Plasma/serum sampling, Procedure: Faecal sample acquisitionPatients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach |
| 7. High-risk gastric lesions | – | Procedure: Breath sampling for volatile marker detection, Procedure: Upper endoscopy with biopsies, Procedure: Plasma/serum sampling, Procedure: Faecal sample acquisitionPatients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, but excluding those with dysplasia (Group 5) |
| 8. Normal and low-risk gastric lesions | – | Procedure: Breath sampling for volatile marker detection, Procedure: Upper endoscopy with biopsies, Procedure: Plasma/serum sampling, Procedure: Faecal sample acquisitionStaged 0-III according to OLGIM. Dysplasia should be excluded |
| 9. Average risk population | – | Procedure: Breath sampling for volatile marker detection, Procedure: Plasma/serum sampling, Procedure: Faecal sample acquisitionAverage risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients (Group 1 and 5) will be predominantly enrolled at the time scheduled for surgery, however also patients undergoing diagnostic procedures (endoscopy) will be eligible Patients without malignant disease but defined colorectal (Groups 2-4) status will be predominantly enrolled prior colonoscopy in out-patient settings. Sampling starting from 1 week after colonoscopy will be allowed if the lesions will not get removed during the index endoscopy Patients without malignant disease but defined gastric mucosal status (Groups 6-8) status will be predominantly enrolled prior upper endoscopy in out-patient settings. Sampling starting from 2 days after upper endoscopy will be allowed if the lesions will not get removed during the index endoscopy Average cancer risk subjects (Group 9) will get enrolled by inviting individuals predominantly selected from the lists of general practitioners.
Key inclusion criteria (8 listed)
- Patients with verifies colorectal cancer (Group 1)
- Patients with verified gastric cancer (Group 5)
- Patients undergoing colonoscopy due to clinical indications (group 2-4)
- Patients undergoing upper endoscopy due to clinical indications (Group 6-8)
- Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 9)
Key exclusion criteria (3 listed)
- Known other active cancer
- Ventilation problems, airway obstruction
- Unwillingness or inability to co-operate
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 |
|---|---|---|
| Breath sampling for volatile marker detectionAcquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology | Procedure or surgery | 1. Colorectal cancer, 2. Colorectal high-risk lesions, 3. Colorectal low-risk adenoma, 4. Group of control (colorectal), 5. Gastric cancer, 6. Gastric dysplasia, 7. High-risk gastric lesions, 8. Normal and low-risk gastric lesions, 9. Average risk population |
| Upper endoscopy with biopsiesUpper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for microbiota testing | Procedure or surgery | 5. Gastric cancer, 6. Gastric dysplasia, 7. High-risk gastric lesions, 8. Normal and low-risk gastric lesions |
| Colonoscopy with biopsies or lesion removal when requiredColonoscopy with proper biopsy or polypectomy material work-up will be used for identification and stratification of colorectal lesions as well as acquisition of biopsies for microbiota testing | Procedure or surgery | 1. Colorectal cancer, 2. Colorectal high-risk lesions, 3. Colorectal low-risk adenoma, 4. Group of control (colorectal) |
| Plasma/serum samplingPlasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination | Procedure or surgery | 1. Colorectal cancer, 2. Colorectal high-risk lesions, 3. Colorectal low-risk adenoma, 4. Group of control (colorectal), 5. Gastric cancer, 6. Gastric dysplasia, 7. High-risk gastric lesions, 8. Normal and low-risk gastric lesions, 9. Average risk population |
| Faecal sample acquisitionFaecal samples will be obtained for faecal occult blood testing as well as microbiota analysis | Procedure or surgery | 1. Colorectal cancer, 2. Colorectal high-risk lesions, 3. Colorectal low-risk adenoma, 4. Group of control (colorectal), 5. Gastric cancer, 6. Gastric dysplasia, 7. High-risk gastric lesions, 8. Normal and low-risk gastric lesions, 9. Average risk population |
| Histological evaluation of the surgery materialThe material obtained during surgery (stomach or colorectal) will be used for confirmation of the diagnosis in cancer groups. Surgery itself will be performed according to the clinical indications, and will not be extended (i.e. cannot be considered a study intervention) | Procedure or surgery | 1. Colorectal cancer, 5. Gastric cancer |
Primary outcome
Performance of nanoarray sensor testing to detect target lesions
Time frame: At the time of breath sampling
Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis
VOCs differentiating the study groups
Time frame: At the time of breath sampling
List of VOCs assayed by GC-MS with statistical difference between the study groups
3 secondary outcomes
Identification of characteristic VOC pattern in risk age groups
Time frame: At the time of sampling
VOC pattern changes following treatment
Time frame: At baseline and every 6 months within 3 year period
Groups of gastrointestinal microbiota correlating to VOCs
Time frame: At the time of sampling
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 21 Aug 2018.
- Background: PubMed 24305596Haick H, Broza YY, Mochalski P, Ruzsanyi V, Amann A. Assessment, origin, and implementation of breath volatile cancer markers. Chem Soc Rev. 2014 Mar 7;43(5):1423-49. doi: 10.1039/c3cs60329f. Epub 2013 Dec 4.
- Background: PubMed 23462808Xu ZQ, Broza YY, Ionsecu R, Tisch U, Ding L, Liu H, Song Q, Pan YY, Xiong FX, Gu KS, Sun GP, Chen ZD, Leja M, Haick H. A nanomaterial-based breath test for distinguishing gastric cancer from benign gastric conditions. Br J Cancer. 2013 Mar 5;108(4):941-50. doi: 10.1038/bjc.2013.44.
- Background: PubMed 24184568Amal H, Leja M, Broza YY, Tisch U, Funka K, Liepniece-Karele I, Skapars R, Xu ZQ, Liu H, Haick H. Geographical variation in the exhaled volatile organic compounds. J Breath Res. 2013 Dec;7(4):047102. doi: 10.1088/1752-7155/7/4/047102. Epub 2013 Nov 1.
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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.
Hossam Haick, Ph.D. principal investigator
Technion, Israel Institute for Technology (Israel)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Adenoma, run by University of Latvia 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 8 inclusion and 3 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 21 Aug 2018. 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 Latvia, Lithuania. 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?
Performance of nanoarray sensor testing to detect target lesions (time frame: At the time of breath sampling). 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?
On the ClinicalTrials.gov record for NCT02332213, which also lists 3 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 21 Aug 2018.