Urothelial CarcinomaNCT00867633
Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan
An observational study of Urothelial Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To study the association between aristolochic acid and urothelial carcinoma in Taiwan Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urothelial Carcinoma
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Mar 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who received nephrectomies
Who may be able to join
- the resected kidney tissue in the tissue bank
Who cannot join
- the patients who had been ever exposed to arsenics, rubber, chemicals, irradiation for pelvis, or received chemotherapy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yeong-Shiau Pu, Ph.D., 886-2-23123456 ext. 65249, yspu@ntu.edu.tw
About this study
Official title: Observational Study of Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan
To study the association between aristolochic acid and urothelial carcinoma in Taiwan
- Conditions
- Urothelial Carcinoma
- Keywords
- urothelial carinoma, aristolochic acid, DNA, adduct
- Medical subject headings
- Carcinoma, Transitional Cell
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 |
|---|---|---|
| Urothelial carcinoma | The DNA samples extracted from the urothelial carcinoma tissue | |
| RCC | the DNA sample extracted from RCC | |
| Non-cancer | The DNA sample extracted from the non-cancerous kidney tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of aristolochic-acid DNA adduct in the samples
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startMar 2009
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867633
- Sponsor's protocol ID
- 200804011R
- Status last verified
- Feb 2012
- First submitted
- 22 Mar 2009
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan
- ClinicalTrials.gov ID
- NCT00867633
- Acronym / sponsor ID
- 200804011R
- Conditions
- Urothelial Carcinoma
- Keywords
- urothelial carinoma, aristolochic acid, DNA, adduct
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Study completion
- Mar 2012 (estimated)
- First posted
- 24 Mar 2009 (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.
To study the association between aristolochic acid and urothelial carcinoma in Taiwan
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Urothelial carcinoma | – | –The DNA samples extracted from the urothelial carcinoma tissue |
| RCC | – | –the DNA sample extracted from RCC |
| Non-cancer | – | –The DNA sample extracted from the non-cancerous kidney tissue |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who received nephrectomies
Key inclusion criteria (1 listed)
- the resected kidney tissue in the tissue bank
Key exclusion criteria (1 listed)
- the patients who had been ever exposed to arsenics, rubber, chemicals, irradiation for pelvis, or received chemotherapy.
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
the incidence of aristolochic-acid DNA adduct in the samples
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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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.
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 Urothelial Carcinoma, 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 1 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 22 Feb 2012. 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 Yeong-Shiau Pu, Ph.D. (886-2-23123456 ext. 65249, yspu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of aristolochic-acid DNA adduct in the samples (time frame: one week). It is what the study was designed to measure, not a finding.
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 22 Feb 2012.