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TerminatedNCT00607425SPIT-LCUpdated Jul 17, 2008

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

An observational study in Non-Small Cell Lung Cancer, sponsored by Scottsdale Healthcare. Terminated. Open to participants aged 40 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-07-17.

Sponsored by Scottsdale Healthcare · Observational

Why this study was terminated
Change in isolation method
Study type
Observational
Model
Case-control
Enrollment
40
Ages
40 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • non-small cell lung cancer
  • screening
  • saliva
  • gene expression
  • healthy control subject
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 40 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Scottsdale Healthcare is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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
05

Study design

Observational model
Case-control
Enrollment
40 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    Non-small cell lung cancer patients

  • 2

    Healthy control subjects

06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00607425
Lead sponsor
Scottsdale Healthcare
Collaborators
University of California, Los Angeles, University of Colorado, Denver, US Department of Veterans Affairs, University of Kansas
First posted
Feb 5, 2008
Start date
Aug 2007
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Jul 17, 2008

Study contacts

Glen J Weiss, MD
principal investigator · TGen Clinical Research Services at Scottsdale Healthcare

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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