Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
genetic linkage analysis
loss of heterozygosity analysis
mutation analysis
polymerase chain reaction
polymorphism analysis
biologic sample preservation procedure
medical chart review
questionnaire administration
evaluation of cancer risk factors
Sponsored by
About this trial
This is an observational trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer
Eligibility Criteria
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
Sites / Locations
- Cancer Research Centre at Weston Park HospitalRecruiting
Outcomes
Primary Outcome Measures
Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples
Secondary Outcome Measures
Analysis of single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples
Genetic changes of lung cancer in plasma DNA samples
Full Information
NCT ID
NCT00693836
First Posted
June 6, 2008
Last Updated
August 9, 2013
Sponsor
Cancer Research Centre at Weston Park Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00693836
Brief Title
Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region
Official Title
Resource for the Study of Lung Cancer Epidemiology in North Trent
Study Type
Observational
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cancer Research Centre at Weston Park Hospital
4. Oversight
5. Study Description
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.
Detailed Description
OBJECTIVES:
Primary
To establish a resource bank of high quality genomic and plasma DNA and tumor and serum samples linked to clinical data obtained from detailed family history and lifestyle questionnaires from patients with lung cancer and from their partners and first-degree relatives for genetic epidemiology studies of lung cancer.
Secondary
To study single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples from patients with lung cancer and from their partners and first-degree relatives.
To study genetic changes of lung cancer in plasma DNA samples from patients with lung cancer and from their partners and first-degree relatives.
OUTLINE: This is a multicenter study.
Patients and their partners complete a detailed, interview-based questionnaire to assess their environmental risk factors for cancer. Information on past medical, social, occupational, and smoking history as well as family history, including any malignancies diagnosed and subsequent causes of death, is collected. First-degree relatives of patients complete an interview-based questionnaire about smoking, occupational, and cancer history. Relatives of patients' partners complete a telephone-administered questionnaire only.
Medical records of patients are reviewed to obtain information on pathological diagnosis and laboratory number, date of diagnosis, stage of disease, performance status, co-morbidities, and treatment plan. Medical records of partners may also be reviewed to obtain information on the incidence of smoking-related malignancies (i.e., cancer of the lung, larynx, esophagus, stomach, bladder, or head and neck).
Patients and their partners and first-degree relatives undergo blood sample collection for laboratory studies. Previously collected tumor samples are obtained from patients. Plasma DNA, lymphocyte DNA, and tumor DNA are analyzed by polymerase chain reaction (PCR) to identify loss of heterozygosity (LOH) between genomic (lymphocyte) DNA and the tumor and plasma DNA. Specific tumor-associated mutations are also analyzed by real-time PCR. Single nucleotide polymorphism studies, including common gene polymorphisms (metabolic genes, DNA repair genes, and tumor suppressor genes), in lung cancer families are also conducted.
A statistical model will be developed for future analysis and will include correlations in genetic alterations in DNA isolated from tumor and plasma, familial aggregation studies, and genetic analysis studies.
PROJECTED ACCRUAL: A total of 2,000 participants (500 patients and 1,500 partners and first-degree relatives [controls]) will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer
7. Study Design
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
genetic linkage analysis
Intervention Type
Genetic
Intervention Name(s)
loss of heterozygosity analysis
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
biologic sample preservation procedure
Intervention Type
Other
Intervention Name(s)
medical chart review
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
evaluation of cancer risk factors
Primary Outcome Measure Information:
Title
Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples
Secondary Outcome Measure Information:
Title
Analysis of single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples
Title
Genetic changes of lung cancer in plasma DNA samples
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penella J. Woll, MD, PhD
Organizational Affiliation
Cancer Research Centre at Weston Park Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penella J. Woll, MD, PhD
Phone
44-114-226-5206
12. IPD Sharing Statement
Learn more about this trial
Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region
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