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

May 14, 2013 updated by: University of Liverpool Cancer Research Centre

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

8300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liverpool Cancer Research Centre

Investigators

Principal Investigator: John K. Field, MA, BDS, PhD, FRCPath, University of Liverpool Cancer Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Field JK, Smith DL, Duffy S, Cassidy A. The Liverpool Lung Project research protocol. Int J Oncol. 2005 Dec;27(6):1633-45.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

ULCRC-LLP
CDR0000554297 (Registry Identifier: PDQ (Physician Data Query))
EU-20735

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.