Breath Gas Analysis for the Diagnosis of Breast Cancer

Mamma Carcinoma Clinical Trial

Official title:

Leistungsbewertungsprüfung: Atemluftanalyse für Die Diagnose Von Brustkrebs, für Die Überwachung Der Therapie Und für Die Voraussage Des Metastasenrisikos

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01105468
• Other study ID #: BC1
• Status: Terminated
• Phase: N/A
• First received: April 8, 2010
• Last updated: January 11, 2013
• Start date: April 2010
• Est. completion date: April 2017

Study information

• Verified date: January 2013
• Source: Ionimed Analytik GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 202
• Est. completion date: April 2017
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mamma Carcinoma

Intervention

Device:
• Breath Collecting Unit
Collect two breath gas samples per patient on one day before surgery
• Breath Collecting Unit
Collect two or more breath gas samples on different days during adjuvant or neo-adjuvant therapy.

Locations

Country	Name	City	State
Austria	Department of Gynecology and Obstetrics, Medical University Innsbruck	Innsbruck	Tirol

Sponsors (2)

Lead Sponsor	Collaborator
Ionimed Analytik GmbH	Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath gas markers	Breath gas markers that allow to distinguish patients with mamma carcinoma from women without carcinoma;	3 years	No