Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers

NCT00897234 | Completed DMC

• 2 other identifiers: 2008NTLS0940809M47482
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at blood samples from patients with non-small cell lung cancer and from healthy volunteers.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Levels of cathepsin D

  Measure plasma CD levels in patients with non-small cell lung cancer and non-smoker healthy controls using mass spectrometry.

  At Routine Follow-Up

Secondary Outcomes (2)

• Levels of fatty acid synthase (FAS)

  At Routine Follow-Up

• Global microRNA expression

  At Routine Follow-Up

Study Arms (2)

Healthy Volunteers

Non-smoking healthy volunteers

Other: Mass Spectrometry

Non-Small Cell Lung Cancer

Patients with non-small cell lung cancer.

Other: Mass Spectrometry

Interventions

Mass Spectrometry OTHER

Levels of Cathepsin D (CD) and fatty acid synthase (FAS) will be measured using isobaric tag labeling coupled with mass spectrometry. RNA concentration will be measured using spectrophometer and purity will be analyzed.

Healthy Volunteers; Non-Small Cell Lung Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who have non-small cell lung cancer (NSCLC) will be recruited from the Masonic Cancer Center at the University of Minnesota. Controls will be non-smoking individuals, age matched to the NSCLC subjects recruited through advertising. Normal controls should not be regularly exposed to second hand smoke.

You may qualify if:

• Non-Small Cell Lung Cancer Patients
• Documented diagnosis of non-small cell lung cancer, any stage and any time point in the course of treatment (i.e., at diagnosis, during any treatment, and during post treatment surveillance)
• Measurable disease by CT scan within the past 4 weeks
• Healthy volunteer
• Non-smoking, defined as \< 5 packs/year history of smoking and cessation of smoking ≥ 6 months ago OR a never smoker
• Not regularly exposed (i.e., daily) to second-hand smoke

You may not qualify if:

• Severe underlying lung disease (i.e., chronic obstructive pulmonary disease with FEV\_1 \< 1.0 L, pulmonary fibrosis, bronchiectasis, cystic fibrosis, etc.) as determined by enrolling researcher.
• Written consent must be given for both subjects and controls.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample collection, one 10 ml purple top EDTA tube, will be collected from each patient and control via venipuncture or from a central line.

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Mass Spectrometry

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Robert A. Kratzke, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: December 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

US (1)