- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00503958
Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
-
Liverpool, Storbritannien, L14 3PE
- Rekrytering
- Cardiothoracic Centre - Liverpool
-
Kontakt:
- Contact Person
- Telefonnummer: 44-151-228-1616
-
-
England
-
Liverpool, England, Storbritannien, L9 7AL
- Rekrytering
- Aintree University Hospital
-
Kontakt:
- Contact Person
- Telefonnummer: 44-151-525-5980
-
Liverpool, England, Storbritannien, L3 9TA
- Rekrytering
- University of Liverpool Cancer Research Centre
-
Kontakt:
- John K. Field, MA, BDS, PhD, FRCPath
- Telefonnummer: 44-151-794-8900
-
Merseyside, England, Storbritannien, CH63 4JY
- Rekrytering
- Clatterbridge Centre for Oncology
-
Kontakt:
- Peter Clark, MD
- Telefonnummer: 44-151-482-7828
- E-post: peter.clark@ccotrust.nhs.uk
-
Prescot Merseyside, England, Storbritannien, L35 5DR
- Rekrytering
- Whiston Hospital
-
Kontakt:
- Ernest Marshall, MD
- Telefonnummer: 44-151-426-1600
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
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)
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: John K. Field, MA, BDS, PhD, FRCPath, University of Liverpool Cancer Research Centre
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ULCRC-LLP
- CDR0000554297 (Registeridentifierare: PDQ (Physician Data Query))
- EU-20735
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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