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Status unknownNCT00693836Updated Aug 12, 2013

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

An observational study in Lung Cancer, sponsored by Cancer Research Centre at Weston Park Hospital. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-12.

Sponsored by Cancer Research Centre at Weston Park Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2008), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer

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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
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

This is the only study on the registry with Cancer Research Centre at Weston Park Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Enrollment
2,000 participants (estimated)
Patient registry
No

Interventions

  • Geneticgenetic linkage analysis
  • Geneticloss of heterozygosity analysis
  • Geneticmutation analysis
  • Geneticpolymerase chain reaction
  • Geneticpolymorphism analysis
  • Otherbiologic sample preservation procedure
  • Othermedical chart review
  • Otherquestionnaire administration
  • Procedureevaluation of cancer risk factors
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What researchers measure

Primary outcomes

  1. Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples

Secondary outcomes

  1. Analysis of single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples

  2. Genetic changes of lung cancer in plasma DNA samples

07

Study locations

1 of 1 sites recruiting
  • Cancer Research Centre at Weston Park Hospital
    Sheffield, England S1O 2SJ, United Kingdom
    • Penella J. Woll, MD, PhD · Contact · 44-114-226-5206
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00693836
Lead sponsor
Cancer Research Centre at Weston Park Hospital
First posted
Jun 9, 2008
Start date
Jan 2006
Primary completion
Oct 2010 (estimated)
Last update
Aug 12, 2013

Study contacts

Penella J. Woll, MD, PhD
principal investigator · Cancer Research Centre at Weston Park Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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