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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00503958
First received: July 17, 2007
Last updated: May 14, 2013
Last verified: November 2007
  Purpose

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.


Condition Intervention
Health Status Unknown
Lung Cancer
Genetic: DNA methylation analysis
Genetic: DNA stability analysis
Genetic: gene expression analysis
Other: epidemiologic study
Other: study of socioeconomic and demographic variables
Procedure: biopsy
Procedure: evaluation of cancer risk factors
Procedure: study of high risk factors

Study Type: Observational
Official Title: Liverpool Lung Project

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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)

Estimated Enrollment: 8300
Study Start Date: August 1998
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.

  Eligibility

Ages Eligible for Study:   45 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503958

Locations
United Kingdom
Aintree University Hospital Recruiting
Liverpool, England, United Kingdom, L9 7AL
Contact: Contact Person    44-151-525-5980      
University of Liverpool Cancer Research Centre Recruiting
Liverpool, England, United Kingdom, L3 9TA
Contact: John K. Field, MA, BDS, PhD, FRCPath    44-151-794-8900      
Clatterbridge Centre for Oncology Recruiting
Merseyside, England, United Kingdom, CH63 4JY
Contact: Peter Clark, MD    44-151-482-7828    peter.clark@ccotrust.nhs.uk   
Whiston Hospital Recruiting
Prescot Merseyside, England, United Kingdom, L35 5DR
Contact: Ernest Marshall, MD    44-151-426-1600      
Cardiothoracic Centre - Liverpool Recruiting
Liverpool, United Kingdom, L14 3PE
Contact: Contact Person    44-151-228-1616      
Sponsors and Collaborators
University of Liverpool Cancer Research Centre
Investigators
Principal Investigator: John K. Field, MA, BDS, PhD, FRCPath University of Liverpool Cancer Research Centre
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00503958     History of Changes
Other Study ID Numbers: ULCRC-LLP, CDR0000554297, EU-20735
Study First Received: July 17, 2007
Last Updated: May 14, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer
small cell lung cancer
health status unknown

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014