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Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer

Primary Purpose

Health Status Unknown, Lung Cancer

Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
DNA methylation analysis
DNA stability analysis
gene expression analysis
epidemiologic study
study of socioeconomic and demographic variables
biopsy
evaluation of cancer risk factors
study of high risk factors
Sponsored by
University of Liverpool Cancer Research Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Health Status Unknown focused on measuring non-small cell lung cancer, small cell lung cancer, health status unknown

Eligibility Criteria

45 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

DISEASE CHARACTERISTICS:

  • Prospective cohort:

    • All residents (n=326,000), aged 45-79, within the designated Liverpool postcode study area will be eligible for entry into the study

      • 7,500 people will be randomly selected from this population via general practitioner's (GP's) lists held by each Primary Care Trust
      • All the GP's who have practices within the study area will be asked to collaborate with the project

  • Case-control:

    • Patients: Newly diagnosed cases of primary lung cancer

      • All cases of epithelial tumors of the trachea, bronchus, and lung will be included
    • Two controls per case who are matched for age (+/- 2 years) and gender and will be randomly selected from the Liverpool Lung Project prospective cohort

PATIENT CHARACTERISTICS:

  • Inclusion Criteria:

    • 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

  • Exclusion Criteria:

    • 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:

  • 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

Sites / Locations

  • University of Liverpool Cancer Research CentreRecruiting
  • Aintree University HospitalRecruiting
  • Clatterbridge Centre for OncologyRecruiting
  • Whiston HospitalRecruiting
  • Cardiothoracic Centre - LiverpoolRecruiting

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
July 17, 2007
Last Updated
May 14, 2013
Sponsor
University of Liverpool Cancer Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00503958
Brief Title
Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer
Official Title
Liverpool Lung Project
Study Type
Observational

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Liverpool Cancer Research Centre

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Status Unknown, Lung Cancer
Keywords
non-small cell lung cancer, small cell lung cancer, health status unknown

7. Study Design

Enrollment
8300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
DNA methylation analysis
Intervention Type
Genetic
Intervention Name(s)
DNA stability analysis
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Other
Intervention Name(s)
epidemiologic study
Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
evaluation of cancer risk factors
Intervention Type
Procedure
Intervention Name(s)
study of high risk factors
Primary Outcome Measure Information:
Title
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
Title
Develop an archive of specimens relating to at-risk individuals and those with lung cancer
Title
Redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability
Title
Identify and assess novel markers of pre-carcinogenesis in high-risk populations
Title
Facilitate the development of new intervention strategies (i.e., chemoprevention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
DISEASE CHARACTERISTICS: Prospective cohort: All residents (n=326,000), aged 45-79, within the designated Liverpool postcode study area will be eligible for entry into the study 7,500 people will be randomly selected from this population via general practitioner's (GP's) lists held by each Primary Care Trust All the GP's who have practices within the study area will be asked to collaborate with the project Case-control: Patients: Newly diagnosed cases of primary lung cancer All cases of epithelial tumors of the trachea, bronchus, and lung will be included Two controls per case who are matched for age (+/- 2 years) and gender and will be randomly selected from the Liverpool Lung Project prospective cohort PATIENT CHARACTERISTICS: Inclusion Criteria: 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 Exclusion Criteria: 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John K. Field, MA, BDS, PhD, FRCPath
Organizational Affiliation
University of Liverpool Cancer Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Liverpool Cancer Research Centre
City
Liverpool
State/Province
England
ZIP/Postal Code
L3 9TA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John K. Field, MA, BDS, PhD, FRCPath
Phone
44-151-794-8900
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-151-525-5980
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Clark, MD
Phone
44-151-482-7828
Email
peter.clark@ccotrust.nhs.uk
Facility Name
Whiston Hospital
City
Prescot Merseyside
State/Province
England
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernest Marshall, MD
Phone
44-151-426-1600
Facility Name
Cardiothoracic Centre - Liverpool
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-151-228-1616

12. IPD Sharing Statement

Citations:
PubMed Identifier
16273220
Citation
Field JK, Smith DL, Duffy S, Cassidy A. The Liverpool Lung Project research protocol. Int J Oncol. 2005 Dec;27(6):1633-45.
Results Reference
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Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer

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