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

Lung Cancer Clinical Trial

Official title:

Liverpool Lung Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00503958
• Other study ID #: ULCRC-LLP
• Secondary ID: CDR0000554297EU-
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2007
• Last updated: May 14, 2013
• Start date: August 1998

Study information

• Verified date: November 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical 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.

PURPOSE: This research study is looking at risk factors and genetic markers in healthy participants and in patients with lung cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8300
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 79 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Health Status Unknown
• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• DNA methylation analysis

• DNA stability analysis

• gene expression analysis

Other:
• epidemiologic study

• study of socioeconomic and demographic variables

Procedure:
• biopsy

• evaluation of cancer risk factors

• study of high risk factors

Locations

Country	Name	City	State
United Kingdom	Aintree University Hospital	Liverpool	England
United Kingdom	Cardiothoracic Centre - Liverpool	Liverpool
United Kingdom	University of Liverpool Cancer Research Centre	Liverpool	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	Whiston Hospital	Prescot Merseyside	England

Sponsors (1)

Lead Sponsor	Collaborator
University of Liverpool Cancer Research Centre

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Develop an archive of specimens relating to at-risk individuals and those with lung cancer
Primary	Redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability
Primary	Identify and assess novel markers of pre-carcinogenesis in high-risk populations
Primary	Facilitate the development of new intervention strategies (i.e., chemoprevention)