NCT00503958

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
Last Updated

May 15, 2013

Status Verified

November 1, 2007

First QC Date

July 17, 2007

Last Update Submit

May 14, 2013

Conditions

Keywords

non-small cell lung cancersmall cell lung cancerhealth status unknown

Outcome Measures

Primary Outcomes (5)

  • 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)

Interventions

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Liverpool Cancer Research Centre

Liverpool, England, L3 9TA, United Kingdom

RECRUITING

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

RECRUITING

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

RECRUITING

Whiston Hospital

Prescot Merseyside, England, L35 5DR, United Kingdom

RECRUITING

Cardiothoracic Centre - Liverpool

Liverpool, L14 3PE, United Kingdom

RECRUITING

Related 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.

    PMID: 16273220BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

DNA MethylationGene Expression ProfilingEpidemiologic StudiesBiopsy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaGenetic TechniquesInvestigative TechniquesEpidemiologic Study CharacteristicsEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, Operative

Study Officials

  • John K. Field, MA, BDS, PhD, FRCPath

    University of Liverpool Cancer Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

August 1, 1998

Last Updated

May 15, 2013

Record last verified: 2007-11

Locations