Study on Systemic and Airway Cytokines and Oxidative Stress in Lung Cancer Patients Undergoing Surgery

NCT00956852 | Terminated

• 1 other identifier: UW 08-249
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer has remained as the top cancer killer in Hong Kong. Even for early resectable stage of lung cancer, only around 60-70% of patients can survive for 5 years after operation, mostly related to disease recurrence. Therefore there is urgent need for predictive biomarkers that can potentially help in monitoring patients for risk of disease recurrence after operation. Recent studies have suggested an important role of oxidative stress in the development of lung cancer and our preliminary data have suggested that some of the oxidative stress markers in blood could be predictive of response to systemic chemotherapy for lung cancer. Apart from potential biomarkers from blood, ongoing study has also been conducted to investigate the predictive role of biomarkers in exhaled breath condensate in lung cancer patients undergoing chemotherapy. Exhaled breath condensate can be collected simply with a disposable commercially available device that allows trapping of breath condensate via a cooling column during normal breathing for 20 minutes. Therefore this study aims at investigating the role of blood and exhaled breath condensate oxidative stress biomarkers before and after surgical lung resection for lung cancer in predicting subsequent clinical outcome, i.e., timing of disease recurrence. Recruited subjects will undergo interval sampling of blood and exhaled breath condensate, without any additional invasive interventions. The study subjects will be followed up for 5 years for subsequent disease recurrence.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time to disease recurrence

  24 months after surgery

Secondary Outcomes (1)

• Disease-free survival

  24 months after surgery

Study Arms (1)

Lung cancer

Non-small cell lung cancer patients undergoing surgical lung resections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early stage NSCLC who undergo curative lung resections in the Division of Cardiothoracic Surgery, Department of Surgery, Queen Mary Hospital will be recruited.

You may qualify if:

• Histologically or cytologically confirmed early-stage non-small cell lung cancer undergoing curative surgical lung resections.
• Life expectancy \> 12 weeks.

You may not qualify if:

• Respiratory failure requiring use of supplemental oxygen therapy.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, buffy coat, red blood cell and exhaled breath condensate samples.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chung-man James Ho

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 9, 2009
• First Posted: August 11, 2009
• Study Start: September 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

HK (1)