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Breath Gas Analysis for the Diagnosis of Breast Cancer

This study has been terminated.
(Sponsor quit partnership in Oncotyrol-Center for Personalized Medicine, and consequential loss of public funding.)
Sponsor:
Collaborator:
Medical University Innsbruck
Information provided by (Responsible Party):
Ionimed Analytik GmbH
ClinicalTrials.gov Identifier:
NCT01105468
First received: April 8, 2010
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Mamma Carcinoma
 Device: Breath Collecting Unit

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Leistungsbewertungsprüfung: Atemluftanalyse für Die Diagnose Von Brustkrebs, für Die Überwachung Der Therapie Und für Die Voraussage Des Metastasenrisikos

Resource links provided by NLM:

MedlinePlus related topics: Cancer Gas
U.S. FDA Resources

Further study details as provided by Ionimed Analytik GmbH:

Primary Outcome Measures:
  • Breath gas markers [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Breath gas markers that allow to distinguish patients with mamma carcinoma from women without carcinoma;


Enrollment: 202
Study Start Date: April 2010
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Mamma Carcinoma, no treatment Device: Breath Collecting Unit
Collect two breath gas samples per patient on one day before surgery
Other Name: BCU
Mamma Carcinoma, treatment Device: Breath Collecting Unit
Collect two or more breath gas samples on different days during adjuvant or neo-adjuvant therapy.
Other Name: BCU
No Mamma Carcinoma diagnosed by X-ray Device: Breath Collecting Unit
Collect two breath gas samples per patient on one day before surgery
Other Name: BCU

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • No informed consent form singed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105468

Locations
Austria
Department of Gynecology and Obstetrics, Medical University Innsbruck
Innsbruck, Tirol, Austria, 6020
Sponsors and Collaborators
Ionimed Analytik GmbH
Medical University Innsbruck
  More Information

No publications provided

Responsible Party: Ionimed Analytik GmbH
ClinicalTrials.gov Identifier: NCT01105468     History of Changes
Other Study ID Numbers: BC1
Study First Received: April 8, 2010
Last Updated: January 11, 2013
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Ionimed Analytik GmbH:
Breath gas analysis
Volatile components in exhaled breath

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013