Mamma CarcinomaNCT01105468
Breath Gas Analysis for the Diagnosis of Breast Cancer
An observational study of Mamma Carcinoma, run by Ionimed Analytik GmbH at 1 site in Austria.
Trial summary
The volatile content of the exhaled breath gas of mamma carcinoma patients will be chemically analyzed by proton-transfer-reaction time of flight mass spectrometry. The goal of the study is to determine typical breath gas components that allow to distinguish patients with mamma carcinoma from women without carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mamma Carcinoma
- What is being tested?
- Breath Collecting Unit
- Type of treatment
- Medical device
- How many people
- 202 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2010to Apr 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 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Mamma carcinoma diagnosed by histology (cases)
- Mamma carcinoma excluded by radiology (controls)
- At the time of diagnosis before surgery
- At the beginning and during chemotherapy;
Who cannot join
- No informed consent form singed
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Gynecology and Obstetrics, Medical University Innsbruck
Innsbruck, Tyrol, 6020
About this study
Official title: Leistungsbewertungsprüfung: Atemluftanalyse für Die Diagnose Von Brustkrebs, für Die Überwachung Der Therapie Und für Die Voraussage Des Metastasenrisikos
The volatile content of the exhaled breath gas of mamma carcinoma patients will be chemically analyzed by proton-transfer-reaction time of flight mass spectrometry.
The goal of the study is to determine typical breath gas components that allow to distinguish patients with mamma carcinoma from women without carcinoma. Further, the investigators will test whether these breath gas markers can be used as tumor markers, which change in a typical manner during the progress of the disease. Finally the data will be investigated for the presence of marker components, that identify patients who will develop metastasis.
- Conditions
- Mamma Carcinoma
- Being tested
- Breath Collecting Unit
- Keywords
- Breath gas analysis, Volatile components in exhaled breath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath Collecting UnitDevice
Also called BCU
Collect two breath gas samples per patient on one day before surgery
Breath Collecting UnitDevice
Also called BCU
Collect two or more breath gas samples on different days during adjuvant or neo-adjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| Mamma Carcinoma, no treatment | Not described Receives: Device: Breath Collecting Unit | |
| Mamma Carcinoma, treatment | Not described Receives: Device: Breath Collecting Unit | |
| No Mamma Carcinoma diagnosed by X-ray | Not described Receives: Device: Breath Collecting Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath gas markers
Breath gas markers that allow to distinguish patients with mamma carcinoma from women without carcinoma;
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2013 (estimated)
- Study completionApr 2017 (estimated)
Why it stopped: Sponsor quit partnership in Oncotyrol-Center for Personalized Medicine, and consequential loss of public funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mamma CarcinomaStudies 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionimed Analytik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University Innsbruck
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105468
- Sponsor's protocol ID
- BC1
- Status last verified
- Jan 2013
- First submitted
- 8 Apr 2010
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leistungsbewertungsprüfung: Atemluftanalyse für Die Diagnose Von Brustkrebs, für Die Überwachung Der Therapie Und für Die Voraussage Des Metastasenrisikos
- ClinicalTrials.gov ID
- NCT01105468
- Acronym / sponsor ID
- BC1
- Conditions
- Mamma Carcinoma
- Keywords
- Breath gas analysis, Volatile components in exhaled breath
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor quit partnership in Oncotyrol-Center for Personalized Medicine, and consequential loss of public funding.
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Ionimed Analytik GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Medical University Innsbruck
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 16 Apr 2010 (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 volatile content of the exhaled breath gas of mamma carcinoma patients will be chemically analyzed by proton-transfer-reaction time of flight mass spectrometry.
The goal of the study is to determine typical breath gas components that allow to distinguish patients with mamma carcinoma from women without carcinoma. Further, the investigators will test whether these breath gas markers can be used as tumor markers, which change in a typical manner during the progress of the disease. Finally the data will be investigated for the presence of marker components, that identify patients who will develop metastasis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mamma Carcinoma, no treatment | – | Device: Breath Collecting Unit |
| Mamma Carcinoma, treatment | – | Device: Breath Collecting Unit |
| No Mamma Carcinoma diagnosed by X-ray | – | Device: Breath Collecting Unit |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- Mamma carcinoma diagnosed by histology (cases)
- Mamma carcinoma excluded by radiology (controls)
- At the time of diagnosis before surgery
- At the beginning and during chemotherapy;
Key exclusion criteria (1 listed)
- No informed consent form singed
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 Collecting UnitAlso: BCUCollect two breath gas samples per patient on one day before surgery | Device | Mamma Carcinoma, no treatment, No Mamma Carcinoma diagnosed by X-ray |
| Breath Collecting UnitAlso: BCUCollect two or more breath gas samples on different days during adjuvant or neo-adjuvant therapy. | Device | Mamma Carcinoma, treatment |
Primary outcome
Breath gas markers
Time frame: 3 years
Breath gas markers that allow to distinguish patients with mamma carcinoma from women without carcinoma;
Results and safety
The study was stopped early (reason given: Sponsor quit partnership in Oncotyrol-Center for Personalized Medicine, and consequential loss of public funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
Related trials for Mamma Carcinoma
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mamma Carcinoma, run by Ionimed Analytik GmbH at 1 site in Austria.
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 1 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: stopped early, as of the sponsor's last update on 14 Jan 2013. 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 Austria. 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 was stopped early (reason given: Sponsor quit partnership in Oncotyrol-Center for Personalized Medicine, and consequential loss of public funding.). Results are not available in the source record.
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?
Breath gas markers (time frame: 3 years). 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 14 Jan 2013.