NCT00558350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

4.2 years

First QC Date

November 13, 2007

Last Update Submit

March 14, 2012

Conditions

Lung Neoplasms

Keywords

lobectomyinflammatory reactionintrapulmonaryintrapleural

Outcome Measures

Primary Outcomes (2)

  • Cytokine levels in blood, bronchial lavage fluid and pleural fluid

    2 years

  • Correlation between cytokine levels and pulmonary morbidity

    2 years

Secondary Outcomes (1)

  • Comparison of this collective with transthoracic esophagectomies and evaluation of the inflammatory reactions (esophageal collective registered:NCT00512265)

    4 years

Study Arms (1)

1

lobectomy / segmentectomy in patients with lung cancer

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • elective lobectomy
  • elective segmentectomy
  • years
  • informed consent given

You may not qualify if:

  • emergency operations
  • pneumonectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Lung NeoplasmsInflammation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Urs Zingg, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2007

First Posted

November 14, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

CH(1)