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Genetic Polymorphisms in UGT1A6 and UGT2B7 in Asian Population: Association With Lung Cancer Phenotype

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by National University Hospital, Singapore.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00717353
First Posted: July 17, 2008
Last Update Posted: January 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National University Hospital, Singapore
  Purpose

Primary

  1. To determine the presence and frequency of novel and known UGT1A6 and UGT2B7 polymorphisms in healthy Chinese, Malay and Indian subjects.
  2. To determine the presence and frequency of novel and known UGT1A6 and UGT2B7 polymorphisms in Chinese lung cancer patients with squamous cell and adenocarcinoma subtype.
  3. To analyze the functional variations in UGT1A6 and UGT2B7 polymorphisms.

Secondary

1 To study the correlation of UGT1A6 and UGT2B7 polymorphisms with lung cancer type.


Condition
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Genetic Polymorphisms in UGT1A6 and UGT2B7 in Asian Population: Association With Lung Cancer Phenotype

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Study Start Date: October 2005
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Lung cancer

Detailed Description:
Germline polymorphisms are inherited genetic variation present in all cells of the body. At molecular level, such variations may affect gene transcription, translation, mRNA stability, protein activity, protein expression (1-3). Mounting evidences have emerged showing that genetic polymorphisms in drug metabolizing genes and DNA repaired genes are major determinants of response to drugs and carcinogens with possible predictive or prognostic value for clinical outcome (4-6). However, only a small number of all polymorphisms discovered have functional significance and it is often difficult to predict this base on nucleotide sequence alone. Genome based studies have generated a wealth of data on genetic polymorphisms far exceeds our knowledge on the function of these variants. Hence, there is an urgent need to characterize the functional and expressional impact of genetic polymorphisms in candidate genes so that appropriate target polymorphisms most likely to affect the phenotype can be selected for larger scale association studies. In this study, we will adopt a novel 2-stage approach to identify and characterize new polymorphisms in the UGT1A6 and 2B7 genes in our Asian population. Data from our initial genotyping work will then be used to optimize the study design of the stage II association study for the generation of hypothesis that lung cancer histology (phenotype) is associated with UGT polymorphisms (genotype). This study will help to advance our understanding in the functional significance and diversity of genetic variants that exist in our population. It may also shed light on the role of UGT in carcinogenesis and will provide vital ground work for future studies of risk assessment, treatment and may allow identification of at risk individual for chemoprevention and adjuvant therapy studies.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Our laboratory has conducted a pilot study to look at UGT1A expression in both normal and cancer tissue using RT PCR. We have found that in UGT1A6 is the predominant UGT1A enzymes expressed in normal lung and the expression of UGT1A6 enzymes is down regulated in lung cancer (unpublished data). The distribution of UGT1A enzymes in the lung suggests that UGT1A6 may be important in the glucuronidation of inhaled UGT substrates including chemicals from tobacco smoking.
Criteria

Inclusion criteria for stage I study

  • Subjects >= 18 years old
  • Hemoglobin >= 8g/dL, Total white cell counts >3.0 x 103/μl
  • ECOG =0

Inclusion criteria for stage II study

  • Chinese ethnicity
  • Patients >18 years old
  • Hemoglobin => 8g/dL, Total white cell counts >3.0 x 103/μl
  • Histologically or cytologically confirmed lung cancer for stage II study
  • Uncontrolled medical conditions such as diabetes, hypertension and coronary artery disease.

Exclusion criteria

  • Histology of small cell lung cancer
  • Medical or psychiatric conditions which may impair the patient's ability to provide informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717353


Locations
Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Wei Peng Yong, MRCP, MB ChB National University Hospital, Singapore
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00717353     History of Changes
Other Study ID Numbers: NS05/25/04
First Submitted: July 16, 2008
First Posted: July 17, 2008
Last Update Posted: January 14, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases