Lung Cancer Clinical Trial; Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region

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Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsored by: Cancer Research Centre at Weston Park Hospital

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00693836

Purpose
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.



Condition Intervention
Lung Cancer
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




MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: Resource for the Study of Lung Cancer Epidemiology in North Trent


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples [ Designated as safety issue: No ]



Secondary Outcome Measures:
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 ]


Estimated Enrollment: 2000
Study Start Date: January 2006
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693836


Locations
United Kingdom, England
Cancer Research Centre at Weston Park Hospital Recruiting
Sheffield, England, United Kingdom, S1O 2SJ
Contact: Penella J. Woll, MD, PhD 44-114-226-5206

Sponsors and Collaborators
Cancer Research Centre at Weston Park Hospital
Investigators
Principal Investigator: Penella J. Woll, MD, PhD Cancer Research Centre at Weston Park Hospital

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000589308, CRC-WPH-USMS-ReSoLuCENT, EU-20826
Study First Received: June 6, 2008
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00693836 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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 placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Small Cell
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Recurrence



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms



ClinicalTrials.gov processed this record on February 10, 2009


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