Colorectal CancerCancerNCT05400408
Chemical Profiling of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study
A study testing VOX in people with Colorectal Cancer and Pancreatic Cancer, run by Scentech Medical Technologies Ltd at 1 site in Israel.
Trial summary
Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Pancreatic Cancer
- What is being tested?
- VOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2024to 31 Mar 2025
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years at the time of consent.
- Scheduled for colonoscopy or Endoscopic Retrograde Cholangio Pancreatography.
- Fasted >6 hours, consuming water only.
- Able to provide informed written consent.
Who cannot join
- Lacks capacity or is unable to provide informed written consent.
- Pregnant or lactating woman.
- Histologically confirmed cancer in any organ.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shamir Medical Center
Be’er Ya‘aqov
Haim Shirin, MD, +972505191475, Haimsh@shamir.gov.il
Haim Shirin, MD
About this study
Official title: Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study.
Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study
Read the detailed description
A diagnostic prospective study with no anticipated risks or constraints. Main Objective: To quantify differences in exhaled breath VOCs of patients with colorectal or pancreatic cancers compared with cohorts without cancer.
- Conditions
- Colorectal Cancer, Pancreatic Cancer
- Being tested
- VOX
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOXDiagnostic test
Breath Biopsy Analysis
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer | Experimental | Subjects who were diagnosed as Colorectal Cancer patients by colonoscopy. Receives: Diagnostic Test: VOX |
| Pancreatic Cancer | Experimental | Subjects who were diagnosed as Pancreatic Cancer patients by Endoscopic Retrograde Cholangio Pancreatography. Receives: Diagnostic Test: VOX |
| Healthy volunteers | Other | Subjects who were found with no Colorectal or Pancreatic malignancies, by either colonoscopy or by Endoscopic Retrograde Cholangio Pancreatography. Receives: Diagnostic Test: VOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of Volatile Organic Compounds that can be related to Colorectal malignancy.
Comparison of identity and concentration of Volatile Organic Compounds profile found among colorectal patients and the identity and concentration of Volatile Organic Compounds profile found among Healthy controls.
Measured: Through the study completion, up to 1 year.
Secondary outcomes (2)
Test Sensitivity and specificity for colorectal polyps.
Comparison of Volatile Organic Compounds found among subjects with and without colorectal polyps.
Measured: Through the study completion, up to 1 year.
Test Sensitivity and specificity for pancreatic cancer.
Comparison of Volatile Organic Compounds found among pancreatic patients and Healthy controls.
Measured: Through the study completion, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 May 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scentech Medical Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haim Shirin, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400408
- Sponsor's protocol ID
- CRCPC-SMC-2021
- Acronym
- Cancer
- Status last verified
- Feb 2024
- First submitted
- 24 May 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD is to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study.
- ClinicalTrials.gov ID
- NCT05400408
- Acronym / sponsor ID
- Cancer / CRCPC-SMC-2021
- Conditions
- Colorectal Cancer, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Scentech Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 1 Jun 2022 (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.
Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study
Detailed description
A diagnostic prospective study with no anticipated risks or constraints. Main Objective: To quantify differences in exhaled breath VOCs of patients with colorectal or pancreatic cancers compared with cohorts without cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer | Experimental | Diagnostic Test: VOXSubjects who were diagnosed as Colorectal Cancer patients by colonoscopy. |
| Pancreatic Cancer | Experimental | Diagnostic Test: VOXSubjects who were diagnosed as Pancreatic Cancer patients by Endoscopic Retrograde Cholangio Pancreatography. |
| Healthy volunteers | Other | Diagnostic Test: VOXSubjects who were found with no Colorectal or Pancreatic malignancies, by either colonoscopy or by Endoscopic Retrograde Cholangio Pancreatography. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 85 years at the time of consent.
- Scheduled for colonoscopy or Endoscopic Retrograde Cholangio Pancreatography.
- Fasted >6 hours, consuming water only.
- Able to provide informed written consent.
Key exclusion criteria (3 listed)
- Lacks capacity or is unable to provide informed written consent.
- Pregnant or lactating woman.
- Histologically confirmed cancer in any organ.
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 |
|---|---|---|
| VOXBreath Biopsy Analysis | Diagnostic test | Colorectal Cancer, Healthy volunteers, Pancreatic Cancer |
Primary outcome
identification of Volatile Organic Compounds that can be related to Colorectal malignancy.
Time frame: Through the study completion, up to 1 year.
Comparison of identity and concentration of Volatile Organic Compounds profile found among colorectal patients and the identity and concentration of Volatile Organic Compounds profile found among Healthy controls.
2 secondary outcomes
Test Sensitivity and specificity for colorectal polyps.
Time frame: Through the study completion, up to 1 year.
Test Sensitivity and specificity for pancreatic cancer.
Time frame: Through the study completion, up to 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No. No IPD is to be shared with other researchers.
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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.
Haim Shirin, MD principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOX in people with Colorectal Cancer and Pancreatic Cancer, run by Scentech Medical Technologies Ltd at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HAREL HERSHTIK (0546641812, harel.hershtik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identification of Volatile Organic Compounds that can be related to Colorectal malignancy. (time frame: Through the study completion, up to 1 year.). 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 7 Feb 2024.