Genetic Epidemiological Study of Lung Cancer in Taiwan an... | NCT00260871

Studies
Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications

NCT00260871

Sponsor

National Health Research Institutes, Taiwan

Status

Unknown status

Last Update Posted

Jul 29, 2011Estimated

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Lung Cancer

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 1, 2005

First Submission Date that Met QC Criteria

Dec 1, 2005

First Posted Date

Dec 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2011

Last Update Posted Date

Jul 29, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Health Research Institutes, TaiwanOTHER

Collaborators

Name	Class
National Taiwan University Hospital	OTHER
Taipei Veterans General Hospital, Taiwan	OTHER_GOV
Chang Gung Memorial Hospital	OTHER
Taichung Veterans General Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

lung adenocarcinoma

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The program project intend to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chao Hsiung, PhD	NHRI	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Biostatistics and Bioinformatics, NHRI		Miaoli County		350	Taiwan

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D000077192	Adenocarcinoma of Lung

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
1.DOH-94-TD-G-111-025
2.DOH-94-TD-G-111-027