Clinical trial NCT00503958: Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer
Official title: Liverpool Lung Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Status Unknown
Lung Cancer
Keywords: non-small cell lung cancer
small cell lung cancer
health status unknown
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-07-19
Enrollment: 8300
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.

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

Primary outcomes:
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
measure: Develop an archive of specimens relating to at-risk individuals and those with lung cancer
measure: Redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability
measure: Identify and assess novel markers of pre-carcinogenesis in high-risk populations
measure: Facilitate the development of new intervention strategies (i.e., chemoprevention)
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool Cancer Research Centre
state: England
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology
state: England
city: Prescot Merseyside
country: United Kingdom
facility: Whiston Hospital
state: England
city: Liverpool
country: United Kingdom
facility: Cardiothoracic Centre - Liverpool
Study officials:
affiliation: University of Liverpool Cancer Research Centre
name: John K. Field, MA, BDS, PhD, FRCPath
role: PRINCIPAL_INVESTIGATOR
References:
citation: Field JK, Smith DL, Duffy S, Cassidy A. The Liverpool Lung Project research protocol. Int J Oncol. 2005 Dec;27(6):1633-45.