Systemic, Intrapulmonary and Pleural Inflammatory Reactio... | NCT00558350

Studies
Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery

NCT00558350

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Mar 15, 2012Estimated

Enrollment

15Actual

Phase

Not provided

Conditions

Lung Neoplasms

Interventions

Not provided

Countries

Switzerland

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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Nov 13, 2007

First Submission Date that Met QC Criteria

Nov 13, 2007

First Posted Date

Nov 14, 2007Estimated

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

Mar 14, 2012

Last Update Posted Date

Mar 15, 2012Estimated

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

Inflammatory reaction in different compartments of the body may have a negative effect on outcome. This study assesses the inflammatory reaction systemically, intrapulmonary and intrapleural by measuring different cytokines. Patients with lung cancer undergoing lobectomy or segmentectomy are included in the study. Hypothesis: The inflammatory reaction in the pleural space is high compared to the systemic and intrapulmonary ones.

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

15Actual

Label	Type	Description	Intervention Names
1		lobectomy / segmentectomy in patients with lung cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cytokine levels in blood, bronchial lavage fluid and pleural fluid		2 years
Correlation between cytokine levels and pulmonary morbidity		2 years

Secondary Outcomes

Measure	Description	Time Frame
Comparison of this collective with transthoracic esophagectomies and evaluation of the inflammatory reactions (esophageal collective registered:NCT00512265)		4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective lobectomy
elective segmentectomy
20-90 years
informed consent given

Exclusion Criteria:

emergency operations
pneumonectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

all patients undergoing lobectomy or segmentectomy for lung cancer at a single institution

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urs Zingg, MD	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel		4031	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D007249	Inflammation

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided