Lung CancerNCT00898209
Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer. (SPORE)
An observational study of Lung Cancer, run by Vanderbilt-Ingram Cancer Center.
Trial summary
RATIONALE: Collecting and storing samples of blood and exhaled breath from patients with cancer and from healthy participants to study in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- protein expression analysis, proteomic profiling and biologic sample preservation procedure
- How many people
- 564 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Dec 2009
- 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 volunteers as well as patients at risk or already identified as having lung cancer.
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Normal healthy volunteer
- At high risk for lung cancer (e.g., > 30-pack year history of smoking; chronic obstructive pulmonary disease; or disease-free after surgical resection of lung cancer)
- Diagnosis of stage I, II, IIIA, IIIB, or IV lung cancer
- Must be willing to allow blood and exhaled breath condensate samples to be stored for genetic testing
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer
RATIONALE: Collecting and storing samples of blood and exhaled breath from patients with cancer and from healthy participants to study in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is collecting and analyzing samples of blood and exhaled breath from patients who have or are at high risk for lung cancer and from healthy participants.
Read the detailed description
OBJECTIVES:
- To evaluate the ability of proteomic patterns in serum and exhaled breath condensate samples to detect and discriminate lung cancer from healthy and from high-risk individuals.
- To correlate proteomic patterns with tumor behavior.
OUTLINE: This is a multicenter study.
Blood and exhaled breath condensate samples are collected, whenever possible, at a time medically indicated for other purposes (e.g., work-up, pre-op, surgical procedures). The samples are used to produce genetic material (i.e., DNA, RNA) and molecular material (i.e., proteins) that will be stored for future studies, including studies that may not be related to lung cancer. Future genetic studies related to lung cancer may include studies of protein expression patterns via matrix-assisted laser desorption/ionization time of flight mass spectrometry that may serve as predictive molecular markers of lung cancer.
Participants complete a 15-minute Lung Spore Database questionnaire at the time of study enrollment to provide information on demographics (e.g., date of birth, address, phone number), medical and smoking history, personal and family history of cancer and cancer treatment, and current medications. Medical records are reviewed at the time of study enrollment and then over approximately 5 years to obtain information, including test results, associated with the diagnosis of cancer. Participants may also be contacted by phone at a later time to answer questions about their health status.
- Conditions
- Lung Cancer
- Being tested
- protein expression analysis, proteomic profiling, biologic sample preservation procedure, laboratory biomarker analysis, matrix-asst laser desorption/ionization time flight mass spectrometry
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein expression analysisGenetic
Blood and exhaled breath condensate will be collected.
proteomic profilingGenetic
Blood and exhaled breath condensate will be collected.
biologic sample preservation procedureOther
Blood and exhaled breath condensate will be collected.
laboratory biomarker analysisOther
Blood and exhaled breath condensate will be collected.
matrix-asst laser desorption/ionization time flight mass spectrometryOther
Blood and exhaled breath condensate will be collected.
questionnaire administrationOther
Questionnaire will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Health Volunteers | Blood and exhaled breath condensate will be collected. Receives: Genetic: protein expression analysis; Genetic: proteomic profiling; Other: biologic sample preservation procedure; Other: laboratory biomarker analysis; Other: matrix-asst laser desorption/ionization time flight mass spectrometry; Other: questionnaire administration | |
| Patients at risk or already identified as having lung cancer | Blood and exhaled breath condensate will be collected. Receives: Genetic: protein expression analysis; Genetic: proteomic profiling; Other: biologic sample preservation procedure; Other: laboratory biomarker analysis; Other: matrix-asst laser desorption/ionization time flight mass spectrometry; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of proteomic patterns to detect and discriminate lung cancer
Serum and exhaled breath condensate samples are collected from healthy and high-risk individual with lung cancer
Measured: Once at study entry
Correlation of proteomic patterns with tumor behavior
Measured: Once at study entry
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 2003
- Primary completionFeb 2009
- Study completionDec 2009
Why it stopped: This study competed with another VICC study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 564 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, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898209
- Sponsor's protocol ID
- VICC THO 0332
- Other IDs
- VU-VICC-THO-0332, VU-VICC-030009
- Status last verified
- Apr 2013
- First submitted
- 9 May 2009
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
- Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer
- ClinicalTrials.gov ID
- NCT00898209
- Acronym / sponsor ID
- VICC THO 0332
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study competed with another VICC study
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2003
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2009 (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: Collecting and storing samples of blood and exhaled breath from patients with cancer and from healthy participants to study in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is collecting and analyzing samples of blood and exhaled breath from patients who have or are at high risk for lung cancer and from healthy participants.
Detailed description
OBJECTIVES:
- To evaluate the ability of proteomic patterns in serum and exhaled breath condensate samples to detect and discriminate lung cancer from healthy and from high-risk individuals.
- To correlate proteomic patterns with tumor behavior.
OUTLINE: This is a multicenter study.
Blood and exhaled breath condensate samples are collected, whenever possible, at a time medically indicated for other purposes (e.g., work-up, pre-op, surgical procedures). The samples are used to produce genetic material (i.e., DNA, RNA) and molecular material (i.e., proteins) that will be stored for future studies, including studies that may not be related to lung cancer. Future genetic studies related to lung cancer may include studies of protein expression patterns via matrix-assisted laser desorption/ionization time of flight mass spectrometry that may serve as predictive molecular markers of lung cancer.
Participants complete a 15-minute Lung Spore Database questionnaire at the time of study enrollment to provide information on demographics (e.g., date of birth, address, phone number), medical and smoking history, personal and family history of cancer and cancer treatment, and current medications. Medical records are reviewed at the time of study enrollment and then over approximately 5 years to obtain information, including test results, associated with the diagnosis of cancer. Participants may also be contacted by phone at a later time to answer questions about their health status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Volunteers | – | Genetic: protein expression analysis, Genetic: proteomic profiling, Other: biologic sample preservation procedure, Other: laboratory biomarker analysis, Other: matrix-asst laser desorption/ionization time flight mass spectrometry, Other: questionnaire administrationBlood and exhaled breath condensate will be collected. |
| Patients at risk or already identified as having lung cancer | – | Genetic: protein expression analysis, Genetic: proteomic profiling, Other: biologic sample preservation procedure, Other: laboratory biomarker analysis, Other: matrix-asst laser desorption/ionization time flight mass spectrometry, Other: questionnaire administrationBlood and exhaled breath condensate will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers as well as patients at risk or already identified as having lung cancer.
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 |
|---|---|---|
| protein expression analysisBlood and exhaled breath condensate will be collected. | Genetic | Health Volunteers, Patients at risk or already identified as having lung cancer |
| proteomic profilingBlood and exhaled breath condensate will be collected. | Genetic | Health Volunteers, Patients at risk or already identified as having lung cancer |
| biologic sample preservation procedureBlood and exhaled breath condensate will be collected. | Other | Health Volunteers, Patients at risk or already identified as having lung cancer |
| laboratory biomarker analysisBlood and exhaled breath condensate will be collected. | Other | Health Volunteers, Patients at risk or already identified as having lung cancer |
| matrix-asst laser desorption/ionization time flight mass spectrometryBlood and exhaled breath condensate will be collected. | Other | Health Volunteers, Patients at risk or already identified as having lung cancer |
| questionnaire administrationQuestionnaire will be completed. | Other | Health Volunteers, Patients at risk or already identified as having lung cancer |
Primary outcome
Ability of proteomic patterns to detect and discriminate lung cancer
Time frame: Once at study entry
Serum and exhaled breath condensate samples are collected from healthy and high-risk individual with lung cancer
Correlation of proteomic patterns with tumor behavior
Time frame: Once at study entry
Results and safety
The study was stopped early (reason given: This study competed with another VICC study). Results are not available in the source record.
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 study chair
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Vanderbilt-Ingram Cancer Center.
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: stopped early, 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.
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: This study competed with another VICC study). 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.
What does the primary outcome measure?
Ability of proteomic patterns to detect and discriminate lung cancer (time frame: Once at study entry). The study lists 2 primary outcomes in all. 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.