Carcinoma, Transitional CellPhase 2NCT00172367
Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma
A Phase 2 study testing Lycopene in people with Carcinoma, Transitional Cell, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Primary Objective: To study if lycopene can improve the biomarker status of urothelial cells in patients with uremia-associated urothelial carcinoma. Secondary Objective: To evaluate the general safety and tolerability of oral lycopene 30 mg per day for 12 weeks in uremic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Transitional Cell
- What is being tested?
- Lycopene
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2006to not given
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have pathologically-proven urothelial carcinoma (UC) with a clinical stage <= T3N0M0
- Patients have no visible or identifiable residual UC after treatment with a life expectancy of > 6 months
- Patients have remaining urothelium at risk of recurrence (transplanted renal unit excluded)
- No other active malignancy. Patients who have other primary malignancies should be treated successfully prior to the study entry and should be in a cure or remission state for at least one year.
- Patients are able to take lycopene capsules orally.
- Patients who sign and give informed consents and are willing to conform to the scheduled sampling of the blood, urine and/or tissue
Who cannot join
- Patients who have clinical stage > T3N0M0 or metastatic disease
- Positive urine cytology. Patients who have positive cytology should be subjected to a serial diagnostic workup which may include renal echo, cystoscopy and ureterorenoscopy, and image studies (intravenous urography, computed tomography, magnetic resonance urography, retrograde or antegrade pyelography). If no recurrent or residual tumors are found, patients are still eligible for the study.
- Patients who have ever received systemic chemotherapy within 12 months
- Patients who have gastrointestinal malabsorption regardless of the etiology
- Have known allergic reaction to tomato or lycopene
- Patients who are participating or will participate in other clinical trials
- Patients who have active urinary tract infection can not be accrued until infection is effectively controlled
- Patient's age is less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Primary Objective: To study if lycopene can improve the biomarker status of urothelial cells in patients with uremia-associated urothelial carcinoma.
Secondary Objective: To evaluate the general safety and tolerability of oral lycopene 30 mg per day for 12 weeks in uremic patients.
Read the detailed description
This is a renal function-stratified phase II chemoprevention trial. After 8 weeks of a run-in and washout period, participants will take lycopene, 30 mg per day for 12 weeks. The expression of intermediate biomarkers will be determined upon study entry after 8 weeks of run-in/washout, and after 6 and 12 weeks of lycopene supplementation. It takes at least 20 weeks to complete the course.
- Conditions
- Carcinoma, Transitional Cell
- Being tested
- Lycopene
- Keywords
- Urothelial carcinoma, Lycopene, uremia, prevention, biomarker, progression, anti-oxidant
- Medical subject headings
- Carcinoma, Transitional Cell, Uremia, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LycopeneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of intermediate biomarker status after lycopene supplementation
Secondary outcomes (1)
safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2006
Why it stopped: This study was for National Science Council project. The study was not funded, so the study was withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Transitional CellStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yeong-Shiau Pu, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172367
- Sponsor's protocol ID
- 930906
- Status last verified
- Nov 2004
- First submitted
- 12 Sep 2005
- Last updated
- 26 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT00172367
- Acronym / sponsor ID
- 930906
- Conditions
- Carcinoma, Transitional Cell
- Keywords
- Urothelial carcinoma, Lycopene, uremia, prevention, biomarker, progression, anti-oxidant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was for National Science Council project. The study was not funded, so the study was withdrawn.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- First posted
- 15 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 Objective: To study if lycopene can improve the biomarker status of urothelial cells in patients with uremia-associated urothelial carcinoma.
Secondary Objective: To evaluate the general safety and tolerability of oral lycopene 30 mg per day for 12 weeks in uremic patients.
Detailed description
This is a renal function-stratified phase II chemoprevention trial. After 8 weeks of a run-in and washout period, participants will take lycopene, 30 mg per day for 12 weeks. The expression of intermediate biomarkers will be determined upon study entry after 8 weeks of run-in/washout, and after 6 and 12 weeks of lycopene supplementation. It takes at least 20 weeks to complete the course.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients have pathologically-proven urothelial carcinoma (UC) with a clinical stage <= T3N0M0
- Patients have no visible or identifiable residual UC after treatment with a life expectancy of > 6 months
- Patients have remaining urothelium at risk of recurrence (transplanted renal unit excluded)
- No other active malignancy. Patients who have other primary malignancies should be treated successfully prior to the study entry and should be in a cure or remission state for at least one year.
- Patients are able to take lycopene capsules orally.
Key exclusion criteria (8 listed)
- Patients who have clinical stage > T3N0M0 or metastatic disease
- Positive urine cytology. Patients who have positive cytology should be subjected to a serial diagnostic workup which may include renal echo, cystoscopy and ureterorenoscopy, and image studies (intravenous urography, computed tomography, magnetic resonance urography, retrograde or antegrade pyelography). If no recurrent or residual tumors are found, patients are still eligible for the study.
- Patients who have ever received systemic chemotherapy within 12 months
- Patients who have gastrointestinal malabsorption regardless of the etiology
- Have known allergic reaction to tomato or lycopene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lycopene | Drug | – |
Primary outcome
changes of intermediate biomarker status after lycopene supplementation
1 secondary outcome
safety and tolerability
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
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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.
Yeong-Shiau Pu, MD, PhD 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?
A Phase 2 study testing Lycopene in people with Carcinoma, Transitional Cell, 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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 26 Sep 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
changes of intermediate biomarker status after lycopene supplementation. 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 26 Sep 2008.