Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening

NCT00607425 | Terminated

• 2 other identifiers: 2007-094IASLC
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a pilot study to test the feasibility of using gene expression from saliva to identify patients with early-stage non-small cell lung cancer (NSCLC). The primary objective of this study is to compare gene expression profiles from saliva from healthy controls and patients with early-stage non-small cell lung cancer. To be eligible, patients with non-small cell lung cancer, must not yet have received treatment for their cancer (surgical removal, chemotherapy, or radiation therapy). Health control participants may participate if they meet eligibility criteria listed below. Eligible enrollees will be asked to submit a one time saliva sample and complete a study questionaire.

Conditions

Non-Small Cell Lung Cancer

Keywords

non-small cell lung cancer; screening; saliva; gene expression; healthy control subject

Study Arms (2)

1

Non-small cell lung cancer patients

2

Healthy control subjects

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Untreated, clinical stage I and II non-small cell lung cancer (NSCLC) patients and matching healthy control subjects will be recruited to participate in this study. Untreated patients have not yet had either complete surgical removal of their lung cancer, any chemotherapy, or any radiation therapy to treat their lung cancer.

You may qualify if:

• Patients with untreated stage I-II NSCLC OR Healthy control subjects: with a \> 20 pack year history of cigarette smoking OR Never smokers (defined as less than 100 cigarettes over subject's lifetime)
• The investigators recognize that pathologic confirmation is not always available prior to surgical resection of a lung mass. To account for this, subjects with a suspicious lung mass concerning for lung cancer, can be enrolled on this trial, and submit a saliva sample prior to surgical resection (ideally within 45 days of planned surgery).
• Adults age 40-79
• Ability to understand the investigational nature of the study and sign the informed consent in accordance with institutional and FDA guidelines

You may not qualify if:

• No active pulmonary infection, i.e. bronchitis or pneumonia for 6 months
• No use of steroid inhalers for \> 6 months
• No other prior malignancy is allowed except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancers from which the patient has been disease-free for 5 years

Sponsors & Collaborators

• Scottsdale Healthcare: lead
• University of California, Los Angeles: collaborator
• University of Colorado, Denver: collaborator
• US Department of Veterans Affairs: collaborator
• University of Kansas: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Glen J Weiss, MD

  TGen Clinical Research Services at Scottsdale Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 17, 2008

Record last verified: 2008-07