Prostate CancerNCT00167024
Application of Genetic Polymorphisms of DNA Repair in The Prediction of Prostate Cancer Susceptibility and Its Clinical Outcome
An observational study of Prostate Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Primary: to investigate the effects of DNA repair gene polymorphisms on prostate cancer susceptibility, pathological grade, disease stage and clinical outcome Secondary: to understand the association between DNA repair gene polymorphism and prostate cancer and provided important information for screening, prevention… Read more about this study
- Who is it for?
- Ages 0 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2005to 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 0 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- prostate cancer approved by pathology
Who cannot join
- combined with other malignancy
- accepting blood transfusion within 6 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chao-Yuan Huang, MD, 886-2-23123456 ext. 5238, cyh0909@ha.mc.ntu.edu.tw
Chao-Yuan Huang, MD
About this study
Primary: to investigate the effects of DNA repair gene polymorphisms on prostate cancer susceptibility, pathological grade, disease stage and clinical outcome Secondary: to understand the association between DNA repair gene polymorphism and prostate cancer and provided important information for screening, prevention and treatment of prostate cancer
Read the detailed description
DNA repair plays a key role in carcinogenesis through the removal and repair of DNA damage induced by endogenous and environmental sources. The DNA repair system included four pathways: 1) Base Excision Repair (BER), 2) Nucleotide Excision Repair (NER), 3) Mismatch Repair (MMR) and 4) Double-Strand Break Repair, including homologous recombination pathway and nonhomologous end-joining repair pathway. Decreased and impaired DNA repair capacity has been reported in various cancers, however, its effect on prostate cancer still under investigated.
Common polymorphisms in DNA repair gene may alter protein function and individual's capacity to repair damaged DNA, hence, influence the cancer susceptibility. Polymorphic variants of DNA repair gene have been found to be associated with cancer susceptibility, but rare studies have investigated their effect on prostate cancer. Since variation in the function of these DNA repair genes also impact a cancer cell's viability or resistance to treatment, genetic variants in DNA repair might serve as a valuable biomarker in forcasting the result of cancer treatment. In fact, some reports have demonstrated the association between polymorphisms of DNA repair genes and results of treatment of various cancers.
For the present study proposal, we focused on several DNA repair genes: X-ray repair cross- complementing group 1 (XRCC1), human oxoguanine glycosylase I (hOGG1), xeroderma pigmentosum complementation group D (XPD), hMSH2, hMLH1 and X-ray repair cross-complementing group 3 (XRCC3), which might have relevance in prostate carcinogenesis based on their known functions. XRCC1 is involved in DNA repair in the base excision pathway, the hOGG1 gene encodes a DNA glycosylase /apurinic-apyrimidinic lyase that catalyzes the excision and removal the 8-OH-dG (8-hydroxy- 2-deoxyguanine) - which is a major form of oxidative DNA damage. The XPD gene codes for a DNA helicase involved in transcription and nucleotide excision repair. The hMSH2 and hMLH1 are genes involved with mismatch repair. The XRCC3 gene encoded a protein in the double-strand break homologous recombinational repair pathways.
In this proposed study, we will also use PCR-based methods to investigate the effects of DNA repair gene polymorphisms on prostate cancer susceptibility, pathological grade, disease stage and clinical outcome. With these efforts, we will further understand the association between DNA repair gene polymorphism and prostate cancer and provided important information for screening, prevention and treatment of prostate cancer.
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, DNA repair gene, genetic polymorphism
- Medical subject headings
- Prostatic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Defined population
- Time perspective
- Other
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chao-Yuan Huang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167024
- Sponsor's protocol ID
- 9461700307
- Status last verified
- Mar 2005
- First submitted
- 12 Sep 2005
- Last updated
- 28 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Genetic Polymorphisms of DNA Repair in The Prediction of Prostate Cancer Susceptibility and Its Clinical Outcome
- ClinicalTrials.gov ID
- NCT00167024
- Acronym / sponsor ID
- 9461700307
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, DNA repair gene, genetic polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2005
- First posted
- 14 Sep 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.
Primary: to investigate the effects of DNA repair gene polymorphisms on prostate cancer susceptibility, pathological grade, disease stage and clinical outcome Secondary: to understand the association between DNA repair gene polymorphism and prostate cancer and provided important information for screening, prevention and treatment of prostate cancer
Detailed description
DNA repair plays a key role in carcinogenesis through the removal and repair of DNA damage induced by endogenous and environmental sources. The DNA repair system included four pathways: 1) Base Excision Repair (BER), 2) Nucleotide Excision Repair (NER), 3) Mismatch Repair (MMR) and 4) Double-Strand Break Repair, including homologous recombination pathway and nonhomologous end-joining repair pathway. Decreased and impaired DNA repair capacity has been reported in various cancers, however, its effect on prostate cancer still under investigated.
Common polymorphisms in DNA repair gene may alter protein function and individual's capacity to repair damaged DNA, hence, influence the cancer susceptibility. Polymorphic variants of DNA repair gene have been found to be associated with cancer susceptibility, but rare studies have investigated their effect on prostate cancer. Since variation in the function of these DNA repair genes also impact a cancer cell's viability or resistance to treatment, genetic variants in DNA repair might serve as a valuable biomarker in forcasting the result of cancer treatment. In fact, some reports have demonstrated the association between polymorphisms of DNA repair genes and results of treatment of various cancers.
For the present study proposal, we focused on several DNA repair genes: X-ray repair cross- complementing group 1 (XRCC1), human oxoguanine glycosylase I (hOGG1), xeroderma pigmentosum complementation group D (XPD), hMSH2, hMLH1 and X-ray repair cross-complementing group 3 (XRCC3), which might have relevance in prostate carcinogenesis based on their known functions. XRCC1 is involved in DNA repair in the base excision pathway, the hOGG1 gene encodes a DNA glycosylase /apurinic-apyrimidinic lyase that catalyzes the excision and removal the 8-OH-dG (8-hydroxy- 2-deoxyguanine) - which is a major form of oxidative DNA damage. The XPD gene codes for a DNA helicase involved in transcription and nucleotide excision repair. The hMSH2 and hMLH1 are genes involved with mismatch repair. The XRCC3 gene encoded a protein in the double-strand break homologous recombinational repair pathways.
In this proposed study, we will also use PCR-based methods to investigate the effects of DNA repair gene polymorphisms on prostate cancer susceptibility, pathological grade, disease stage and clinical outcome. With these efforts, we will further understand the association between DNA repair gene polymorphism and prostate cancer and provided important information for screening, prevention and treatment of prostate cancer.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- prostate cancer approved by pathology
Key exclusion criteria (2 listed)
- combined with other malignancy
- accepting blood transfusion within 6 months
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 28 Nov 2005.
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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-Yuan Huang, MD principal investigator
National Taiwan University Hospital
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 Prostate Cancer, run by National Taiwan University Hospital 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 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 28 Nov 2005. 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?
Contact Chao-Yuan Huang, MD (886-2-23123456 ext. 5238, cyh0909@ha.mc.ntu.edu.tw), or a site near the patient. 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 28 Nov 2005.