Breast CancerNCT01292369
Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study
An observational study of Breast Cancer and Colon Cancer, run by Rambam Health Care Campus at 2 sites in Israel.
Trial summary
The concept of breath testing for various diseases has been around since ancient greece. It has been hypothesized that cancer is generating a unique pattern of compounds in patients' breath. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Colon Cancer
- How many people
- 560 participants
- Where
- 2 sitesIsrael
- Study dates
- Feb 2011to Dec 2011
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women coming for medical tests: 1. Women coming for a breast biopsy following a suspicious breast imaging result. 2. Men and women coming for a colonoscopy, reffered by their family physician, due to complaints indicating the possibility of colon cancer.
Who may be able to join
- Men and women attending Rambam medical center for either breast biopsy or colonoscopy.
- Suspicious finding on breast imaging requiring a biopsy.
- Complaints indicating the possibility of colon cancer: Blood in stool, weight loss, constipation, anemia, family history of colon cancer.
Who cannot join
- Other known active malignancy.
- History of malignant disease and treatments.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
RAMBAM medical center
Haifa, 31096
Zahava Galimidi, Dr., 972-4-8543684, z_gallimidi@rambam.health.gov.il
Zahava Galimidi, Dr.
- Not yet recruiting
Carmel medical center
Haifa
Ori Segol, MD, 04-8250356, ori_segol@clalit.org.il
Ori Segol, MD
About this study
Official title: Observational Study Aimed to Characterize a System for Breast and Colon Cancer Diagnosis by Breath Testing - NaNose Study
The concept of breath testing for various diseases has been around since ancient greece. It has been hypothesized that cancer is generating a unique pattern of compounds in patients' breath. This study is trying to characterize a novel system, based on nanoparticles technology, for cancer diagnosis through breath samples.
Read the detailed description
Cancer is accompanied by increased oxidative stress and induction of polymorphic cytochrome P- 450 mixed oxidase enzymes (CYP). Both processes affect the abundance of volatile organic compounds (VOCs) in the breath because oxidative stress causes lipid peroxidation of polyunsaturated fatty acids in membranes, producing alkanes and methylalkanes which are catabolized by CYP.
In the Technion labs, a new system for breath samples diagnosis, is being developed. The system is based on Nanoparticles technology.
The current study will try to identify colon and breast cancer patients through their breath samples and discriminate them from healthy individuals.
Men and women coming for colonoscopy or breast biopsy will be recruited for the study. Breath samples will be taken from all volunteers before the medical test. Subjects with positive cancer results by biopsy will be the test groups for both diseases, all others will be the control.
The research goal is to test the NaNose system ability to discriminate between healthy and sick.
- Conditions
- Breast Cancer, Colon Cancer
- Keywords
- breath test, colon cancer, breast cancer
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | Women diagnosed with breast cancer by a positive biopsy test after mammography. | |
| Breast control | Women with negative biopsy result done due to a suspicious mammography exam. | |
| Colon cancer | Men and women diagnosed with colon cancer by a positive colonoscopy and biopsy. | |
| Colon control | Men and women with negative colonoscopy and biopsy tested due to complaints indicating the possibility of colon cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
System performance
Sensitivity and specificity of NaNose system in diagnosing cancer
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292369
- Sponsor's protocol ID
- RMB-0566.CTIL
- Status last verified
- Aug 2011
- First submitted
- 6 Feb 2011
- Last updated
- 18 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Aimed to Characterize a System for Breast and Colon Cancer Diagnosis by Breath Testing - NaNose Study
- ClinicalTrials.gov ID
- NCT01292369
- Acronym / sponsor ID
- RMB-0566.CTIL
- Conditions
- Breast Cancer, Colon Cancer
- Keywords
- breath test, colon cancer, breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Feb 2011 (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 concept of breath testing for various diseases has been around since ancient greece. It has been hypothesized that cancer is generating a unique pattern of compounds in patients' breath. This study is trying to characterize a novel system, based on nanoparticles technology, for cancer diagnosis through breath samples.
Detailed description
Cancer is accompanied by increased oxidative stress and induction of polymorphic cytochrome P- 450 mixed oxidase enzymes (CYP). Both processes affect the abundance of volatile organic compounds (VOCs) in the breath because oxidative stress causes lipid peroxidation of polyunsaturated fatty acids in membranes, producing alkanes and methylalkanes which are catabolized by CYP.
In the Technion labs, a new system for breath samples diagnosis, is being developed. The system is based on Nanoparticles technology.
The current study will try to identify colon and breast cancer patients through their breath samples and discriminate them from healthy individuals.
Men and women coming for colonoscopy or breast biopsy will be recruited for the study. Breath samples will be taken from all volunteers before the medical test. Subjects with positive cancer results by biopsy will be the test groups for both diseases, all others will be the control.
The research goal is to test the NaNose system ability to discriminate between healthy and sick.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | – | –Women diagnosed with breast cancer by a positive biopsy test after mammography. |
| Breast control | – | –Women with negative biopsy result done due to a suspicious mammography exam. |
| Colon cancer | – | –Men and women diagnosed with colon cancer by a positive colonoscopy and biopsy. |
| Colon control | – | –Men and women with negative colonoscopy and biopsy tested due to complaints indicating the possibility of colon cancer. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women coming for medical tests: 1. Women coming for a breast biopsy following a suspicious breast imaging result. 2. Men and women coming for a colonoscopy, reffered by their family physician, due to complaints indicating the possibility of colon cancer.
Key inclusion criteria (3 listed)
- Men and women attending Rambam medical center for either breast biopsy or colonoscopy.
- Suspicious finding on breast imaging requiring a biopsy.
- Complaints indicating the possibility of colon cancer: Blood in stool, weight loss, constipation, anemia, family history of colon cancer.
Key exclusion criteria (2 listed)
- Other known active malignancy.
- History of malignant disease and treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
System performance
Time frame: 10 months
Sensitivity and specificity of NaNose system in diagnosing cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2011.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colon Cancer, run by Rambam Health Care Campus at 2 sites 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 3 inclusion and 2 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 18 Aug 2011. 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 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 Zahava Galimidi, Dr. (972-4-8543684, z_gallimidi@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System performance (time frame: 10 months). 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 18 Aug 2011.