NCT00693836

Brief Summary

RATIONALE: Gathering information about genetic and environmental factors from patients with lung cancer and their partners and first-degree relatives may help doctors learn more about the disease. PURPOSE: This clinical trial is looking at the patterns, causes, and control of disease in patients with lung cancer in the North Trent (England) region.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Last Updated

August 12, 2013

Status Verified

December 1, 2008

Enrollment Period

4.8 years

First QC Date

June 6, 2008

Last Update Submit

August 9, 2013

Conditions

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent non-small cell lung cancerextensive stage small cell lung cancerlimited stage small cell lung cancerrecurrent small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples

Secondary Outcomes (2)

  • Analysis of single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples

  • Genetic changes of lung cancer in plasma DNA samples

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Patient meeting the following criteria: * Pathologically confirmed lung cancer or planning to undergo lung cancer surgery pending pathological confirmation * Evidence of active disease (i.e., not in remission) * Meets 1 of the following criteria: * 60 years of age and under * Has a first-degree relative with lung cancer who is 60 years of age and under * Has two or more first- or second-degree relatives with lung cancer at any age * Control meeting the following criteria: * Co-habiting partner of patient OR first-degree relative of patient or their partner * 18 years of age and over * Resides within the North Trent Cancer Network region PATIENT CHARACTERISTICS: * Able and willing to complete study procedures PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

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

Interventions

Genetic LinkagePolymerase Chain ReactionAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic PhenomenaNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesDNA Fingerprinting

Study Officials

  • Penella J. Woll, MD, PhD

    Cancer Research Centre at Weston Park Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2008

First Posted

June 9, 2008

Study Start

January 1, 2006

Primary Completion

October 1, 2010

Last Updated

August 12, 2013

Record last verified: 2008-12

Locations