Lung CancerNCT00693836
Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region
An observational study of Lung Cancer, run by Cancer Research Centre at Weston Park Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- genetic linkage analysis, loss of heterozygosity analysis and mutation analysis
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2006to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Penella J. Woll, MD, PhD, 44-114-226-5206
About this study
Official title: Resource for the Study of Lung Cancer Epidemiology in North Trent
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.
- Conditions
- Lung Cancer
- Being tested
- genetic linkage analysis, loss of heterozygosity analysis, mutation analysis, polymerase chain reaction, polymorphism analysis
- 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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic linkage analysisGenetic
loss of heterozygosity analysisGenetic
mutation analysisGenetic
polymerase chain reactionGenetic
polymorphism analysisGenetic
biologic sample preservation procedureOther
medical chart reviewOther
questionnaire administrationOther
evaluation of cancer risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples
Secondary outcomes (2)
Analysis of single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples
Genetic changes of lung cancer in plasma DNA samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startJan 2006
- Primary completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research Centre at Weston Park Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Penella J. Woll, MD, PhD, Principal investigator, Cancer Research Centre at Weston Park Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693836
- Sponsor's protocol ID
- CRC-WPH-USMS-ReSoLuCENT
- Other IDs
- CDR0000589308, EU-20826
- Status last verified
- Dec 2008
- First submitted
- 6 Jun 2008
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resource for the Study of Lung Cancer Epidemiology in North Trent
- ClinicalTrials.gov ID
- NCT00693836
- Acronym / sponsor ID
- CRC-WPH-USMS-ReSoLuCENT
- Conditions
- Lung Cancer
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Cancer Research Centre at Weston Park HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Oct 2010 (estimated)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic linkage analysis | Genetic | – |
| loss of heterozygosity analysis | Genetic | – |
| mutation analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| polymorphism analysis | Genetic | – |
| biologic sample preservation procedure | Other | – |
| medical chart review | Other | – |
| questionnaire administration | Other | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
Primary outcome
Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples
2 secondary outcomes
Analysis of single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples
Genetic changes of lung cancer in plasma DNA samples
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penella J. Woll, MD, PhD principal investigator
Cancer Research Centre at Weston Park Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Cancer Research Centre at Weston Park Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.