Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region
Recruitment status was: Recruiting
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.
Genetic: genetic linkage analysis
Genetic: loss of heterozygosity analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: biologic sample preservation procedure
Other: medical chart review
Other: questionnaire administration
Procedure: evaluation of cancer risk factors
|Official Title:||Resource for the Study of Lung Cancer Epidemiology in North Trent|
- Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples [ Designated as safety issue: No ]
- Analysis of single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples [ Designated as safety issue: No ]
- Genetic changes of lung cancer in plasma DNA samples [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693836
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Principal Investigator:||Penella J. Woll, MD, PhD||Cancer Research Centre at Weston Park Hospital|