Trial Information

Resource for the Study of Lung Cancer Epidemiology in North Trent

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.