Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer - Full Text View

Sponsored by:	University of Liverpool Cancer Research Centre
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00503958

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 randomized phase I trial is studying risk factors and genetic markers in healthy participants and in patients with lung cancer.

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

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	Liverpool Lung Project

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

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

Locations

United Kingdom
Cardiothoracic Centre - Liverpool	Recruiting
Liverpool, United Kingdom, L14 3PE
Contact: Contact Person 44-151-228-1616
United Kingdom, England
Aintree University Hospital	Recruiting
Liverpool, England, United Kingdom, L9 7AL
Contact: Contact Person 44-151-525-5980
Clatterbridge Centre for Oncology	Recruiting
Merseyside, England, United Kingdom, CH63 4JY
Contact: Peter Clark, MD 44-151-482-7828 peter.clark@ccotrust.nhs.uk
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
Whiston Hospital	Recruiting
Prescot Merseyside, England, United Kingdom, L35 5DR
Contact: Ernest Marshall, MD 44-151-426-1600

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000554297, ULCRC-LLP, EU-20735
Study First Received:	July 17, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00503958 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

non-small cell lung cancer
small cell lung cancer
health status unknown
non-small cell lung cancer
small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Small Cell
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Non-small Cell Lung Cancer
Healthy
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on May 07, 2009