Breath Gas Analysis for the Diagnosis of Breast Cancer

NCT ID: NCT01105468

Last Updated: 2013-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mamma Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Mamma Carcinoma, no treatment

Breath Collecting Unit

Intervention Type DEVICE

Collect two breath gas samples per patient on one day before surgery

Mamma Carcinoma, treatment

Breath Collecting Unit

Intervention Type DEVICE

Collect two or more breath gas samples on different days during adjuvant or neo-adjuvant therapy.

No Mamma Carcinoma diagnosed by X-ray

Breath Collecting Unit

Intervention Type DEVICE

Collect two breath gas samples per patient on one day before surgery

Interventions

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Breath Collecting Unit

Collect two breath gas samples per patient on one day before surgery

Intervention Type DEVICE

Breath Collecting Unit

Collect two or more breath gas samples on different days during adjuvant or neo-adjuvant therapy.

Intervention Type DEVICE

Other Intervention Names

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BCU BCU

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role collaborator

Ionimed Analytik GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Gynecology and Obstetrics, Medical University Innsbruck

Innsbruck, Tyrol, Austria

Site Status

Countries

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Austria

Other Identifiers

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BC1

Identifier Type: -

Identifier Source: org_study_id

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