Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: 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
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: genetic linkage analysis Type: Genetic
Name: loss of heterozygosity analysis Type: Genetic
Name: mutation analysis Type: Genetic
Name: polymerase chain reaction Type: Genetic
Name: polymorphism analysis Type: Genetic
Name: biologic sample preservation procedure Type: Other
Name: medical chart review Type: Other
Name: questionnaire administration Type: Other
Name: evaluation of cancer risk factors Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Status: Recruiting
Contact: Penella J. Woll, MD, PhD - 44-114-226-5206
Start Date
January 2006
Sponsors
Cancer Research Centre at Weston Park Hospital
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page