Lung CancerNCT00260871
Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications
An observational study of Lung Cancer, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and environmental factors. In this grant proposal, we propose to map the loci of susceptibility genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- 1,500 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2002to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The program project intend to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma.
Who may be able to join
- lung adenocarcinoma
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Biostatistics and Bioinformatics, NHRI
Miaoli County, 350
About this study
Official title: Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications-focusing on Female Lung Adenocarcinoma (GEFLAC)
Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and environmental factors. In this grant proposal, we propose to map the loci of susceptibility genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. We focus on a unique pathological type of a unique population in order to reduce heterogeneity of the genetic background. Compared with western women, female Chinese population has a high prevalence of lung adenocarcinoma. Our reasoning is that if we focus on a specific sub-type, which has a familial basis, we will increase the probability of identifying genes associated with female lung adenocarcinoma. The primary goal of this study is to identify the genetic and environmental determinants of female lung adenocarcinoma, and study the relationship between gene polymorphisms and clinical manifestation profiling of lung cancer.
Read the detailed description
This research proposal intends to integrate epidemiologists, biostatisticians, clinicians, molecular biologists/geneticists to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma, and to study the relationship between gene polymorphisms and clinical outcomes of lung cancer patients. Our objective is to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect lung cancer, especially female lung adenocarcinoma.
The specific aims of this subproject include:
- Establish and maintain the research network that will recruit and follow up the subjects and families for the GEFLAC study; keeping control of the progress of the study.
- Coordinate all the subprojects such as integrating genotyping data with clinical data and environment data.
- Continue to employ the candidate gene approach to examine the contribution of specific genes to the lung cancer.
- Generate genotyping data for candidate genes in the exploring stage and prioritize SNPs of candidate genes for large scale studies.
- Identify susceptible genes/candidate genes to develop multiplex PCR for screening.
- Conditions
- Lung Cancer
- Keywords
- lung adenocarcinoma, genetic epidemiology, environmental factors, genetic map, coordination center
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startMay 2002
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University
- Investigators
- Chao Hsiung, PhD, Study director, NHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260871
- Sponsor's protocol ID
- 94LCP005
- Other IDs
- 1.DOH-94-TD-G-111-025, 2.DOH-94-TD-G-111-027
- Status last verified
- Jul 2011
- First submitted
- 1 Dec 2005
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications-focusing on Female Lung Adenocarcinoma (GEFLAC)
- ClinicalTrials.gov ID
- NCT00260871
- Acronym / sponsor ID
- 94LCP005
- Conditions
- Lung Cancer
- Keywords
- lung adenocarcinoma, genetic epidemiology, environmental factors, genetic map, coordination center
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University
- Study start
- May 2002
- First posted
- 2 Dec 2005 (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.
Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and environmental factors. In this grant proposal, we propose to map the loci of susceptibility genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. We focus on a unique pathological type of a unique population in order to reduce heterogeneity of the genetic background. Compared with western women, female Chinese population has a high prevalence of lung adenocarcinoma. Our reasoning is that if we focus on a specific sub-type, which has a familial basis, we will increase the probability of identifying genes associated with female lung adenocarcinoma. The primary goal of this study is to identify the genetic and environmental determinants of female lung adenocarcinoma, and study the relationship between gene polymorphisms and clinical manifestation profiling of lung cancer.
Detailed description
This research proposal intends to integrate epidemiologists, biostatisticians, clinicians, molecular biologists/geneticists to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma, and to study the relationship between gene polymorphisms and clinical outcomes of lung cancer patients. Our objective is to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect lung cancer, especially female lung adenocarcinoma.
The specific aims of this subproject include:
- Establish and maintain the research network that will recruit and follow up the subjects and families for the GEFLAC study; keeping control of the progress of the study.
- Coordinate all the subprojects such as integrating genotyping data with clinical data and environment data.
- Continue to employ the candidate gene approach to examine the contribution of specific genes to the lung cancer.
- Generate genotyping data for candidate genes in the exploring stage and prioritize SNPs of candidate genes for large scale studies.
- Identify susceptible genes/candidate genes to develop multiplex PCR for screening.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The program project intend to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma.
Key inclusion criteria (1 listed)
- lung adenocarcinoma
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
- Related InfoLink provided by the sponsor.
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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.
Chao Hsiung, PhD study director
NHRI
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 National Health Research Institutes, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 29 Jul 2011. 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 29 Jul 2011.