NCT00717353

Brief Summary

Primary

  1. 1.To determine the presence and frequency of novel and known UGT1A6 and UGT2B7 polymorphisms in healthy Chinese, Malay and Indian subjects.
  2. 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. 3.To analyze the functional variations in UGT1A6 and UGT2B7 polymorphisms.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2008

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

9.2 years

First QC Date

July 16, 2008

Last Update Submit

January 13, 2014

Conditions

Lung Cancer

Study Arms (1)

1

Lung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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UGT1A enzymes expressed in normal lung and the expression of UGT1A6 enzymes is down regulated in lung cancer (unpublished data).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.

You may qualify if:

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

You may not qualify if:

  • Histology of small cell lung cancer
  • Medical or psychiatric conditions which may impair the patient's ability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (2)

  • Desai AA, Innocenti F, Ratain MJ. UGT pharmacogenomics: implications for cancer risk and cancer therapeutics. Pharmacogenetics. 2003 Aug;13(8):517-23. doi: 10.1097/01.fpc.0000054116.14659.e5.

    PMID: 12893990BACKGROUND

  • Saeki M, Saito Y, Jinno H, Tanaka-Kagawa T, Ohno A, Ozawa S, Ueno K, Kamakura S, Kamatani N, Komamura K, Kitakaze M, Sawada J. Single nucleotide polymorphisms and haplotype frequencies of UGT2B4 and UGT2B7 in a Japanese population. Drug Metab Dispos. 2004 Sep;32(9):1048-54.

    PMID: 15319348BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Wei Peng Yong, MRCP, MB ChB

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 17, 2008

Study Start

October 1, 2005

Primary Completion

December 1, 2014

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

SG(1)