Non-Small Cell Lung CancerSPIT-LCNCT00607425
Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening
An observational study of Non-Small Cell Lung Cancer, run by Scottsdale Healthcare.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Non-small cell lung cancer patients | |
| 2 | Healthy control subjects |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Change in isolation method
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scottsdale Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of Colorado, Denver, US Department of Veterans Affairs, University of Kansas
- Investigators
- Glen J Weiss, MD, Principal investigator, TGen Clinical Research Services at Scottsdale Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607425
- Sponsor's protocol ID
- 2007-094
- Other IDs
- IASLC
- Acronym
- SPIT-LC
- Status last verified
- Jul 2008
- First submitted
- 22 Jan 2008
- Last updated
- 17 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT00607425
- Acronym / sponsor ID
- SPIT-LC / 2007-094
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, screening, saliva, gene expression, healthy control subject
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in isolation method
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Scottsdale HealthcareUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of Colorado, Denver, US Department of Veterans Affairs, University of Kansas
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 5 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Non-small cell lung cancer patients |
| 2 | – | –Healthy control subjects |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Change in isolation method). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen J Weiss, MD principal investigator
TGen Clinical Research Services at Scottsdale Healthcare
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Scottsdale Healthcare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in isolation method). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2008.