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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Lung Cancer
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruiting
Recruitment Status
NCT00693836
Primary Trial ID Number
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.
Research Details
  • 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.
Phase
N/A
Study Design
N/A
Study Type
Observational
Intervention
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 Arm Groups : , , , , , , , ,

Intervention Type
See Interventions above
Primary Outcome Measures
  • Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples; null
Secondary Outcome Measures
  • Analysis of single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples; null; Genetic changes of lung cancer in plasma DNA samples; null
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
2000
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Weston Park Hospital
Sheffield
England
S1O 2SJ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Resource for the Study of Lung Cancer Epidemiology in North Trent
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CRC-WPH-USMS-ReSoLuCENT
Sponsor(s)
Cancer Research Centre at Weston Park Hospital
Key Dates

Recruitment Start Date

Jan 2006

Recruitment End Date

Oct 2010

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

06 Jun 2008

Last Updated

09 Aug 2013