Clinical trial NCT00607425: Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening
Official title: Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-Small Cell Lung Cancer
Keywords: non-small cell lung cancer
screening
saliva
gene expression
healthy control subject
Lead sponsor: Scottsdale Healthcare
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of Colorado, Denver
name: US Department of Veterans Affairs
name: University of Kansas
First posted: 2008-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
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.

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.


Eligibility criteria: Inclusion Criteria:

1. 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).
2. Adults age 40-79
3. Ability to understand the investigational nature of the study and sign the informed consent in accordance with institutional and FDA guidelines

Exclusion Criteria:

1. No active pulmonary infection, i.e. bronchitis or pneumonia for 6 months
2. No use of steroid inhalers for \> 6 months
3. 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TGen Clinical Research Services at Scottsdale Healthcare
name: Glen J Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: