Lung CancerNCT00899262
Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers
An observational study of Lung Cancer and Tobacco Use Disorder, run by South West Wales Cancer Institute at 2 sites in United Kingdom.
Trial summary
RATIONALE: Collecting and storing samples of sputum and tissue to study in the laboratory may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking samples of sputum and tissue from lung cancer patients, participants at high risk for developing lung cancer, and from healthy… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Tobacco Use Disorder
- What is being tested?
- immunohistochemistry staining method, laboratory biomarker analysis and sputum cytology
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2008to Apr 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Diagnosis of lung cancer
- At high risk for developing lung cancer
- Non-high-risk smoking or non-smoking volunteer (control)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Prince Philip Hospital
Llanelli, Wales, SA14 8QF
Contact Person, 44-1554-75-65-67
- Recruiting
South West Wales Cancer Institute
Swansea, Wales, SA2 8PP
Paul D. Lewis, BSc, PhD, 44-1792-295-222, p.d.lewis@swansea.ac.uk
About this study
Official title: Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)
RATIONALE: Collecting and storing samples of sputum and tissue to study in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking samples of sputum and tissue from lung cancer patients, participants at high risk for developing lung cancer, and from healthy volunteers (both smokers and non-smokers).
Read the detailed description
OBJECTIVES:
- To test and make a preliminary assessment of the sensitivity and specificity of Fourier transform infrared technology (FTIR) for use in the early detection of lung cancer in sputum samples from patients who have or participants at high risk for developing lung cancer and from non-high-risk smoking and non-smoking volunteers.
- To permit identification of specific metabolic biomarkers within FTIR spectra that can distinguish between lung cancer, high-risk, and non-high-risk cases.
OUTLINE: This is a multicenter study.
Sputum samples and endobronchial biopsy tissue specimens are collected prior to routine bronchoscopy as part of a standard clinical assessment for the early detection of lung cancer. Sputum samples are examined for levels of bronchial and non-bronchial cells using established cytological and immunohistochemical procedures. Samples are also examined for metabolic biomarkers using Fourier transform infrared spectroscopy (FTIR) to generate complete metabolic fingerprints (i.e., spectra) that can distinguish metabolic differences between cancer, non-cancer, and early disease (i.e., dysplasia or metaplasia). These molecular biomarkers, which are detected within FTIR spectra, may be further analyzed in matched endobronchial biopsy tissue samples for histological confirmation. Additional clinico-pathological data is collected for each participant to allow development of predictive statistical models from the data.
All study participants are followed annually.
- Conditions
- Lung Cancer, Tobacco Use Disorder
- Being tested
- immunohistochemistry staining method, laboratory biomarker analysis, sputum cytology, Fourier transform infrared spectroscopy, diagnostic bronchoscopy
- Keywords
- lung cancer, tobacco use disorder
- Medical subject headings
- Lung Neoplasms, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
sputum cytologyOther
Fourier transform infrared spectroscopyProcedure or surgery
diagnostic bronchoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a cost-effective, high-throughput, and non-invasive screening test using Fourier transform infrared technology for detection of early lung cancer in sputum of high-risk people
Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages
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 completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South West Wales Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Paul D. Lewis, BSc, PhD, Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899262
- Sponsor's protocol ID
- CDR0000599372
- Other IDs
- SWWCI-MEDLUNG, UKCRN-4682, EU-20862
- Status last verified
- Jun 2009
- First submitted
- 9 May 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
Publications
Lewis PD, Lewis KE, Ghosal R, Bayliss S, Lloyd AJ, Wills J, Godfrey R, Kloer P, Mur LA. Evaluation of FTIR spectroscopy as a diagnostic tool for lung cancer using sputum. BMC Cancer. 2010 Nov 23;10:640. doi: 10.1186/1471-2407-10-640.
PubMed 21092279
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)
- ClinicalTrials.gov ID
- NCT00899262
- Acronym / sponsor ID
- CDR0000599372
- Conditions
- Lung Cancer, Tobacco Use Disorder
- Keywords
- lung cancer, tobacco use disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- South West Wales Cancer InstituteUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (estimated)
- 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 sputum and tissue to study in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking samples of sputum and tissue from lung cancer patients, participants at high risk for developing lung cancer, and from healthy volunteers (both smokers and non-smokers).
Detailed description
OBJECTIVES:
- To test and make a preliminary assessment of the sensitivity and specificity of Fourier transform infrared technology (FTIR) for use in the early detection of lung cancer in sputum samples from patients who have or participants at high risk for developing lung cancer and from non-high-risk smoking and non-smoking volunteers.
- To permit identification of specific metabolic biomarkers within FTIR spectra that can distinguish between lung cancer, high-risk, and non-high-risk cases.
OUTLINE: This is a multicenter study.
Sputum samples and endobronchial biopsy tissue specimens are collected prior to routine bronchoscopy as part of a standard clinical assessment for the early detection of lung cancer. Sputum samples are examined for levels of bronchial and non-bronchial cells using established cytological and immunohistochemical procedures. Samples are also examined for metabolic biomarkers using Fourier transform infrared spectroscopy (FTIR) to generate complete metabolic fingerprints (i.e., spectra) that can distinguish metabolic differences between cancer, non-cancer, and early disease (i.e., dysplasia or metaplasia). These molecular biomarkers, which are detected within FTIR spectra, may be further analyzed in matched endobronchial biopsy tissue samples for histological confirmation. Additional clinico-pathological data is collected for each participant to allow development of predictive statistical models from the data.
All study participants are followed annually.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| sputum cytology | Other | – |
| Fourier transform infrared spectroscopy | Procedure or surgery | – |
| diagnostic bronchoscopy | Procedure or surgery | – |
Primary outcome
Development of a cost-effective, high-throughput, and non-invasive screening test using Fourier transform infrared technology for detection of early lung cancer in sputum of high-risk people
Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Results publication: PubMed 21092279Lewis PD, Lewis KE, Ghosal R, Bayliss S, Lloyd AJ, Wills J, Godfrey R, Kloer P, Mur LA. Evaluation of FTIR spectroscopy as a diagnostic tool for lung cancer using sputum. BMC Cancer. 2010 Nov 23;10:640. doi: 10.1186/1471-2407-10-640.
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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.
Paul D. Lewis, BSc, PhD principal investigator
Swansea University
2 sites 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 and Tobacco Use Disorder, run by South West Wales Cancer Institute at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a cost-effective, high-throughput, and non-invasive screening test using Fourier transform infrared technology for detection of early lung cancer in sputum of high-risk people. 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?
On the ClinicalTrials.gov record for NCT00899262, which also lists 1 linked publication.
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 26 Aug 2013.