Breath Gas Analysis for the Diagnosis of Breast Cancer

January 11, 2013 updated by: Ionimed Analytik GmbH

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Department of Gynecology and Obstetrics, Medical University Innsbruck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mamma Carcinoma, no treatment
Device: Breath Collecting Unit
Collect two breath gas samples per patient on one day before surgery
Other Names:
  • BCU
Device: Breath Collecting Unit
Collect two or more breath gas samples on different days during adjuvant or neo-adjuvant therapy.
Other Names:
  • BCU
Mamma Carcinoma, treatment
Device: Breath Collecting Unit
Collect two breath gas samples per patient on one day before surgery
Other Names:
  • BCU
Device: Breath Collecting Unit
Collect two or more breath gas samples on different days during adjuvant or neo-adjuvant therapy.
Other Names:
  • 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 Names:
  • BCU
Device: Breath Collecting Unit
Collect two or more breath gas samples on different days during adjuvant or neo-adjuvant therapy.
Other Names:
  • BCU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath gas markers
Time Frame: 3 years
Breath gas markers that allow to distinguish patients with mamma carcinoma from women without carcinoma;
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionimed Analytik GmbH

Collaborators

Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

April 1, 2013

Study Completion (ANTICIPATED)

April 1, 2017

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 15, 2010

First Posted (ESTIMATE)

April 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BC1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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