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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00693836
First received: June 6, 2008
Last updated: August 9, 2013
Last verified: December 2008
  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

Study Type: Observational
Official Title: Resource for the Study of Lung Cancer Epidemiology in North Trent

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00693836     History of Changes
Other Study ID Numbers: CRC-WPH-USMS-ReSoLuCENT, CDR0000589308, EU-20826
Study First Received: June 6, 2008
Last Updated: August 9, 2013
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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014