Health Status UnknownNCT00503958
Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer
An observational study of Health Status Unknown and Lung Cancer, run by University of Liverpool Cancer Research Centre at 5 sites in United Kingdom.
Trial summary
RATIONALE: Environmental exposure and genetic predisposition may affect the risk of developing cancer later in life. Learning about genetic markers and the long-term effects of environmental exposure may help the study of lung cancer in the future. Read more about this study
- Who is it for?
- Ages 45 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Status Unknown, Lung Cancer
- What is being tested?
- DNA methylation analysis, DNA stability analysis and gene expression analysis
- Type of treatment
- Surgery or procedure
- How many people
- 8,300 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Aug 1998to not given
- 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 45 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prospective cohort:
- Age 45-79
- Living within the Liverpool electoral wards
- Case-control:
- Upper age limit of 80 years old
- Resident within Liverpool Lung Project area
Who cannot join
- Both cohorts:
- Unable to provide competent informed consent
- Ineligible to approach based on consultant/clinical team advice
- Infectious respiratory disease (i.e., chest infection and are on antibiotics) within the past 3 months
- Untreated pulmonary tuberculosis within the past 3 months
- PRIOR CONCURRENT THERAPY:
Show all 13Show fewer
- Participant and/or patient must not have had any of the following treatments within the last 3 months and is not planning to undergo any of them:
- Cardiac surgery
- Thoracic surgery
- Carotid artery surgery
- Abdominal surgery
- Chemotherapy
- Deep x-ray therapy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Recruiting
University of Liverpool Cancer Research Centre
Liverpool, England, L3 9TA
John K. Field, MA, BDS, PhD, FRCPath, 44-151-794-8900
- Recruiting
Aintree University Hospital
Liverpool, England, L9 7AL
Contact Person, 44-151-525-5980
- Recruiting
Cardiothoracic Centre - Liverpool
Liverpool, L14 3PE
Contact Person, 44-151-228-1616
- Recruiting
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
Peter Clark, MD, 44-151-482-7828, peter.clark@ccotrust.nhs.uk
- Recruiting
Whiston Hospital
Prescot Merseyside, England, L35 5DR
Ernest Marshall, MD, 44-151-426-1600
About this study
Official title: Liverpool Lung Project
RATIONALE: Environmental exposure and genetic predisposition may affect the risk of developing cancer later in life. Learning about genetic markers and the long-term effects of environmental exposure may help the study of lung cancer in the future.
PURPOSE: This research study is looking at risk factors and genetic markers in healthy participants and in patients with lung cancer.
Read the detailed description
OBJECTIVES:
- To prepare a molecular genetic and epidemiological risk assessment model based on the analysis of environmental exposures and genetic predisposition, which will provide an algorithm to measure an individual's risk for developing lung cancer.
- To develop an archive of specimens relating to at-risk individuals and those with lung cancer.
- To redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability.
- To identify and assess novel markers of pre-carcinogenesis in our high-risk populations.
- To facilitate the development of new intervention strategies (i.e., chemoprevention).
OUTLINE: This is a multicenter study.
Participants and/or patients undergo tumor tissue, sputum, and blood sample collection periodically. Samples are analyzed via fields of expression and methylation profiling and genetic instability. Samples are also archived.
Complete lifetime lifestyle, residential, environmental tobacco smoke, and occupational history are assessed in the first year and then in year five and year ten. Participants who return for follow-up complete a shorter questionnaire aimed at recording change over the interval since their last attendance.
PROJECTED ACCRUAL: 800 patients and 7,500 healthy participants will be accrued for this study.
- Conditions
- Health Status Unknown, Lung Cancer
- Being tested
- DNA methylation analysis, DNA stability analysis, gene expression analysis, epidemiologic study, study of socioeconomic and demographic variables
- Keywords
- non-small cell lung cancer, small cell lung cancer, health status unknown
- 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.
DNA methylation analysisGenetic
DNA stability analysisGenetic
gene expression analysisGenetic
epidemiologic studyOther
study of socioeconomic and demographic variablesOther
biopsyProcedure or surgery
evaluation of cancer risk factorsProcedure or surgery
study of high risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Prepare a molecular genetic and epidemiological risk assessment model based on the analysis of environmental exposures and genetic predisposition, which will provide an algorithm to measure an individual's risk for developing lung cancer
Develop an archive of specimens relating to at-risk individuals and those with lung cancer
Redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability
Identify and assess novel markers of pre-carcinogenesis in high-risk populations
Facilitate the development of new intervention strategies (i.e., chemoprevention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startAug 1998
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 Health Status UnknownStudies 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
- 8,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liverpool Cancer Research Centre
- Sponsor type
- University, hospital or other
- Investigators
- John K. Field, MA, BDS, PhD, FRCPath, Principal investigator, University of Liverpool Cancer Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503958
- Sponsor's protocol ID
- ULCRC-LLP
- Other IDs
- CDR0000554297, EU-20735
- Status last verified
- Nov 2007
- First submitted
- 17 Jul 2007
- Last updated
- 15 May 2013
- Results posted
- No
Publications
Field JK, Smith DL, Duffy S, Cassidy A. The Liverpool Lung Project research protocol. Int J Oncol. 2005 Dec;27(6):1633-45.
PubMed 16273220
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liverpool Lung Project
- ClinicalTrials.gov ID
- NCT00503958
- Acronym / sponsor ID
- ULCRC-LLP
- Conditions
- Health Status Unknown, Lung Cancer
- Keywords
- non-small cell lung cancer, small cell lung cancer, health status unknown
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,300 participants (estimated)
- Lead sponsor
- University of Liverpool Cancer Research CentreUniversity, hospital or other
- Study start
- Aug 1998
- First posted
- 19 Jul 2007 (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: Environmental exposure and genetic predisposition may affect the risk of developing cancer later in life. Learning about genetic markers and the long-term effects of environmental exposure may help the study of lung cancer in the future.
PURPOSE: This research study is looking at risk factors and genetic markers in healthy participants and in patients with lung cancer.
Detailed description
OBJECTIVES:
- To prepare a molecular genetic and epidemiological risk assessment model based on the analysis of environmental exposures and genetic predisposition, which will provide an algorithm to measure an individual's risk for developing lung cancer.
- To develop an archive of specimens relating to at-risk individuals and those with lung cancer.
- To redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability.
- To identify and assess novel markers of pre-carcinogenesis in our high-risk populations.
- To facilitate the development of new intervention strategies (i.e., chemoprevention).
OUTLINE: This is a multicenter study.
Participants and/or patients undergo tumor tissue, sputum, and blood sample collection periodically. Samples are analyzed via fields of expression and methylation profiling and genetic instability. Samples are also archived.
Complete lifetime lifestyle, residential, environmental tobacco smoke, and occupational history are assessed in the first year and then in year five and year ten. Participants who return for follow-up complete a shorter questionnaire aimed at recording change over the interval since their last attendance.
PROJECTED ACCRUAL: 800 patients and 7,500 healthy participants will be accrued for this study.
Study design
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (13 listed)
- Participant and/or patient must not have had any of the following treatments within the last 3 months and is not planning to undergo any of them:
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 methylation analysis | Genetic | – |
| DNA stability analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| epidemiologic study | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| biopsy | Procedure or surgery | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Prepare a molecular genetic and epidemiological risk assessment model based on the analysis of environmental exposures and genetic predisposition, which will provide an algorithm to measure an individual's risk for developing lung cancer
Develop an archive of specimens relating to at-risk individuals and those with lung cancer
Redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability
Identify and assess novel markers of pre-carcinogenesis in high-risk populations
Facilitate the development of new intervention strategies (i.e., chemoprevention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
- Background: PubMed 16273220Field JK, Smith DL, Duffy S, Cassidy A. The Liverpool Lung Project research protocol. Int J Oncol. 2005 Dec;27(6):1633-45.
Related trials for Health Status Unknown
Active, not recruiting
Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome
Conditions Influencing Health Status, Healthy
Active, not recruiting
Patients Navigators in Facilitating Weight Management in Obese Participants
Health Status Unknown, Obesity
Active, not recruiting
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
Body Mass Index 25 or Greater, BRCA1 Gene Mutation
Active, not recruiting
Your Health Matters! (Tu Salud ¡Si Cuenta!): Promoting Healthy Lifestyles in Latino Families
Family Member, Health Status Unknown
Active, not recruiting
Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
Health Status Unknown, Elevated PSA
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.
Clatterbridge Centre for Oncology
Merseyside, United Kingdom
John K. Field, MA, BDS, PhD, FRCPath principal investigator
University of Liverpool Cancer Research Centre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Status Unknown and Lung Cancer, run by University of Liverpool Cancer Research Centre at 5 sites in United Kingdom.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Prepare a molecular genetic and epidemiological risk assessment model based on the analysis of environmental exposures and genetic predisposition, which will provide an algorithm to measure an individual's risk for developing lung cancer. The study lists 5 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 NCT00503958, 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 15 May 2013.