Healthy, no Evidence of DiseaseNCT00899457
Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants
An observational study of Healthy, no Evidence of Disease and Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about the development of cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease, Lung Cancer
- What is being tested?
- proteomic profiling, biologic sample preservation procedure and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2008to Aug 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy, non-smokers.
DISEASE CHARACTERISTICS:
- Healthy participant
- No history of smoking
- No history of cancer
PATIENT CHARACTERISTICS:
- SWOG performance status 0
- No clinically apparent bleeding diathesis
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Molecular Predictors of Lung Cancer Behavior: Controls
RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about the development of cancer.
PURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer development using tissue samples from healthy participants.
Read the detailed description
OBJECTIVES:
- To obtain biological specimens from healthy participants with no known risk of lung cancer to use as controls in the study of lung cancer progression.
- To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.
OUTLINE: Serum, urine, sputum, and buccal cell samples are collected. Patients also undergo bronchoscopy for collection of bronchial tissue and bronchial brush samples. The samples are used for genomic and proteomic studies to identify new molecular abnormalities specific to the development of lung cancer.
- Conditions
- Healthy, no Evidence of Disease, Lung Cancer
- Being tested
- proteomic profiling, biologic sample preservation procedure, laboratory biomarker analysis, bronchoscopy
- Keywords
- squamous cell lung cancer, non-small cell lung cancer, small cell lung cancer, healthy, no evidence of disease
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proteomic profilingGenetic
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
biologic sample preservation procedureOther
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
laboratory biomarker analysisOther
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
bronchoscopyProcedure or surgery
Collection of breath condensate.
| Study group | Role | What they receive |
|---|---|---|
| Healthy, non-smokers | Not described Receives: Genetic: proteomic profiling; Other: biologic sample preservation procedure; Other: laboratory biomarker analysis; Procedure: bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of biological specimens to use as controls in the study of lung cancer progression
Specimens are collected from healthy participants with no known risk of lung cancer
Measured: Off study date, up to one year
Secondary outcomes (2)
Identification of new molecular abnormalities specific to the development of squamous cell carcinoma of the lung
Measured: off-study date, up to one year
Selection of important genes/proteins differentially expressed between study groups (e.g., normal vs low-grade vs high-grade vs invasive) and between normal smokers vs normal non-smokers
Measured: off-study date, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startApr 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, no Evidence of DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Pierre P. Massion, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899457
- Sponsor's protocol ID
- VICC THO 0734
- Other IDs
- P50CA090949, P30CA068485, VU-VICC-THO-0734, VICC-THO-0734
- Status last verified
- Apr 2013
- First submitted
- 9 May 2009
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Predictors of Lung Cancer Behavior: Controls
- ClinicalTrials.gov ID
- NCT00899457
- Acronym / sponsor ID
- VICC THO 0734
- Conditions
- Healthy, no Evidence of Disease, Lung Cancer
- Keywords
- squamous cell lung cancer, non-small cell lung cancer, small cell lung cancer, healthy, no evidence of disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 May 2009 (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.
RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about the development of cancer.
PURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer development using tissue samples from healthy participants.
Detailed description
OBJECTIVES:
- To obtain biological specimens from healthy participants with no known risk of lung cancer to use as controls in the study of lung cancer progression.
- To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.
OUTLINE: Serum, urine, sputum, and buccal cell samples are collected. Patients also undergo bronchoscopy for collection of bronchial tissue and bronchial brush samples. The samples are used for genomic and proteomic studies to identify new molecular abnormalities specific to the development of lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy, non-smokers | – | Genetic: proteomic profiling, Other: biologic sample preservation procedure, Other: laboratory biomarker analysis, Procedure: bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy, non-smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proteomic profilingCollection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath | Genetic | Healthy, non-smokers |
| biologic sample preservation procedureCollection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath | Other | Healthy, non-smokers |
| laboratory biomarker analysisCollection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath | Other | Healthy, non-smokers |
| bronchoscopyCollection of breath condensate. | Procedure or surgery | Healthy, non-smokers |
Primary outcome
Collection of biological specimens to use as controls in the study of lung cancer progression
Time frame: Off study date, up to one year
Specimens are collected from healthy participants with no known risk of lung cancer
2 secondary outcomes
Identification of new molecular abnormalities specific to the development of squamous cell carcinoma of the lung
Time frame: off-study date, up to one year
Selection of important genes/proteins differentially expressed between study groups (e.g., normal vs low-grade vs high-grade vs invasive) and between normal smokers vs normal non-smokers
Time frame: off-study date, up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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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.
Pierre P. Massion, MD principal investigator
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, no Evidence of Disease and Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Collection of biological specimens to use as controls in the study of lung cancer progression (time frame: Off study date, up to one year). It is what the study was designed to measure, not a finding.
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 24 Jun 2014.