Lung CancerNCT00717353
Genetic Polymorphisms in UGT1A6 and UGT2B7 in Asian Population: Association With Lung Cancer Phenotype
An observational study of Lung Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- Not given
- Where
- 1 siteSingapore
- Study dates
- Oct 2005to Dec 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
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UGT1A enzymes expressed in normal lung and the expression of UGT1A6 enzymes is down regulated in lung cancer (unpublished data).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.
Who may be able to join
- 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.
Who cannot join
- Histology of small cell lung cancer
- Medical or psychiatric conditions which may impair the patient's ability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Primary
- To determine the presence and frequency of novel and known UGT1A6 and UGT2B7 polymorphisms in healthy Chinese, Malay and Indian subjects.
- 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.
- 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.
Read the 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.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Lung cancer |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startOct 2005
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Wei Peng Yong, MRCP, MB ChB, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717353
- Sponsor's protocol ID
- NS05/25/04
- Status last verified
- Jan 2014
- First submitted
- 16 Jul 2008
- Last updated
- 14 Jan 2014
- Results posted
- No
Publications
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.
PubMed 12893990Saeki 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.
PubMed 15319348
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphisms in UGT1A6 and UGT2B7 in Asian Population: Association With Lung Cancer Phenotype
- ClinicalTrials.gov ID
- NCT00717353
- Acronym / sponsor ID
- NS05/25/04
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2014 (estimated)
- First posted
- 17 Jul 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.
Primary
- To determine the presence and frequency of novel and known UGT1A6 and UGT2B7 polymorphisms in healthy Chinese, Malay and Indian subjects.
- 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.
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Subjects >= 18 years old
- Hemoglobin >= 8g/dL, Total white cell counts >3.0 x 103/μl
- ECOG =0
- Chinese ethnicity
- Patients >18 years old
Key exclusion criteria (2 listed)
- Histology of small cell lung cancer
- Medical or psychiatric conditions which may impair the patient's ability to provide informed consent.
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 14 Jan 2014.
- Background: PubMed 12893990Desai 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.
- Background: PubMed 15319348Saeki 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.
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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.
Wei Peng Yong, MRCP, MB ChB principal investigator
National University Hospital, Singapore
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 University Hospital, Singapore at 1 site in Singapore.
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 8 inclusion and 2 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 14 Jan 2014. 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 Singapore. 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?
On the ClinicalTrials.gov record for NCT00717353, which also lists 2 linked publications.
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 14 Jan 2014.