Breath Gas Analysis for the Diagnosis of Breast Cancer | NCT01105468

Studies
Breath Gas Analysis for the Diagnosis of Breast Cancer

NCT01105468

Sponsor

Ionimed Analytik GmbH

Status

Terminated

Last Update Posted

Jan 14, 2013Estimated

Enrollment

202Actual

Phase

Not provided

Conditions

Mamma Carcinoma

Interventions

Breath Collecting Unit
Breath Collecting Unit

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor quit partnership in Oncotyrol-Center for Personalized Medicine, and consequential loss of public funding.

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Apr 2013Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

Apr 8, 2010

First Submission Date that Met QC Criteria

Apr 15, 2010

First Posted Date

Apr 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2013

Last Update Posted Date

Jan 14, 2013Estimated

Name	Class
Medical University Innsbruck	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

202Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breath Collecting Unit	Device	Collect two breath gas samples per patient on one day before surgery	Mamma Carcinoma, no treatment No Mamma Carcinoma diagnosed by X-ray

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gynecology and Obstetrics, Medical University Innsbruck		Innsbruck	Tyrol	6020	Austria