Lung CancerNCT00897650
Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With Lung Cancer
An observational study of Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- DNA/RNA sequencing and expression levels, Protein expression analysis and Lung tumor biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jul 2017
- 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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People who have or may have lung cancer.
Who may be able to join
- Diagnosis of suspected lung cancer or lung cancer
Who cannot join
- Inability to undergo therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Molecular Fingerprints in Lung Cancer: Predicting Tumor Response to Therapy
RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of predicting response to treatment in patients with lung cancer.
Read the detailed description
OBJECTIVES:
- To determine protein and/or RNA expression patterns capable of predicting tumor response to therapy in tumor tissue samples from patients with lung cancer or suspected of having lung cancer.
- To characterize the genes and proteins found to be predictive of response in order to help elucidate the molecular biology underlying cancer chemosensitivity.
- To evaluate DNA mutations found within the lung cancer sample which may be predictive of response or resistance to certain therapeutic agents.
OUTLINE: Patients undergo collection of tumor tissue by percutaneous fine needle aspiration, core biopsy, thoracentesis, or during any medically indicated procedure involving removal of lung cancer tissue. Tissue samples are analyzed by a variety of techniques, including DNA sequencing, RNA sequencing and expression levels, protein assessment [by immunohistochemistry, western blot, Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-MS]). The goal of these studies is to identify of gene mutations, gene expression levels, and proteins predictive of treatment response. Blood samples are also collected to obtain normal DNA for analysis.
After completion of study, patients will be followed until their death.
- Conditions
- Lung Cancer
- Being tested
- DNA/RNA sequencing and expression levels, Protein expression analysis, Lung tumor biopsy, Blood sample
- Keywords
- lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA/RNA sequencing and expression levelsGenetic
Lung tumor tissue will be collected.
Protein expression analysisGenetic
Also called Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI), Immunohistochemistry, Western blot, RPPA
Lung tumor tissue will be collected.
Lung tumor biopsyProcedure or surgery
Tissue will be collected by percutaneous fine needle aspiration, a percutaneous core biopsy, or during a medically indicated procedure during which lung tumor tissue will be removed
Blood sampleProcedure or surgery
Patients will be asked for a venous blood sample
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | Patients with a diagnosis of invasive lung cancer. Receives: Genetic: DNA/RNA sequencing and expression levels; Genetic: Protein expression analysis; Procedure: Lung tumor biopsy; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA, RNA, and Protein expression patterns and mutational analysis
DNA, RNA, and Protein expression patterns and mutation status in lung tumor tissue that are capable of predicting tumor response to therapy
Measured: After lung tumor tissue and blood collection.
Secondary outcomes (1)
Characterization of genes and proteins predictive of response to therapy
Identify genes and proteins predictive of response to therapy and that can be used to identify novel mechanisms underlying lung cancer behavior
Measured: After lung tumor tissue and blood collection
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 startDec 2005
- Primary completionJul 2016
- Study completionJul 2017
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
- 204 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, Christine Lovly, MD, PhD, Vanderbilt-Ingram Cancer Center
- Investigators
- Christine Lovly, MD, PhD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897650
- Sponsor's protocol ID
- VICC THO 0547
- Other IDs
- P30CA068485, VU-VICC-THO-0547, P50CA090949
- Status last verified
- Jul 2017
- First submitted
- 9 May 2009
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Fingerprints in Lung Cancer: Predicting Tumor Response to Therapy
- ClinicalTrials.gov ID
- NCT00897650
- Acronym / sponsor ID
- VICC THO 0547
- Conditions
- Lung Cancer
- Keywords
- lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2005
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2017 (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 tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of predicting response to treatment in patients with lung cancer.
Detailed description
OBJECTIVES:
- To determine protein and/or RNA expression patterns capable of predicting tumor response to therapy in tumor tissue samples from patients with lung cancer or suspected of having lung cancer.
- To characterize the genes and proteins found to be predictive of response in order to help elucidate the molecular biology underlying cancer chemosensitivity.
- To evaluate DNA mutations found within the lung cancer sample which may be predictive of response or resistance to certain therapeutic agents.
OUTLINE: Patients undergo collection of tumor tissue by percutaneous fine needle aspiration, core biopsy, thoracentesis, or during any medically indicated procedure involving removal of lung cancer tissue. Tissue samples are analyzed by a variety of techniques, including DNA sequencing, RNA sequencing and expression levels, protein assessment [by immunohistochemistry, western blot, Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-MS]). The goal of these studies is to identify of gene mutations, gene expression levels, and proteins predictive of treatment response. Blood samples are also collected to obtain normal DNA for analysis.
After completion of study, patients will be followed until their death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | Genetic: DNA/RNA sequencing and expression levels, Genetic: Protein expression analysis, Procedure: Lung tumor biopsy, Procedure: Blood samplePatients with a diagnosis of invasive lung cancer. |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People who have or may have lung cancer.
Key inclusion criteria (1 listed)
- Diagnosis of suspected lung cancer or lung cancer
Key exclusion criteria (1 listed)
- Inability to undergo therapy
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 |
|---|---|---|
| DNA/RNA sequencing and expression levelsLung tumor tissue will be collected. | Genetic | Lung cancer |
| Protein expression analysisAlso: Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI), Immunohistochemistry, Western blot, RPPALung tumor tissue will be collected. | Genetic | Lung cancer |
| Lung tumor biopsyTissue will be collected by percutaneous fine needle aspiration, a percutaneous core biopsy, or during a medically indicated procedure during which lung tumor tissue will be removed | Procedure or surgery | Lung cancer |
| Blood samplePatients will be asked for a venous blood sample | Procedure or surgery | Lung cancer |
Primary outcome
DNA, RNA, and Protein expression patterns and mutational analysis
Time frame: After lung tumor tissue and blood collection.
DNA, RNA, and Protein expression patterns and mutation status in lung tumor tissue that are capable of predicting tumor response to therapy
1 secondary outcome
Characterization of genes and proteins predictive of response to therapy
Time frame: After lung tumor tissue and blood collection
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 19 Jul 2017.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
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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.
Christine Lovly, MD, PhD study chair
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site 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?
The sponsor lists 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
DNA, RNA, and Protein expression patterns and mutational analysis (time frame: After lung tumor tissue and blood collection.). 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 19 Jul 2017.