Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma
NCT ID: NCT00172367
Last Updated: 2008-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
80 participants
INTERVENTIONAL
2006-01-31
Brief Summary
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Secondary Objective: To evaluate the general safety and tolerability of oral lycopene 30 mg per day for 12 weeks in uremic patients.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Lycopene
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Principal Investigators
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Yeong-Shiau Pu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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930906
Identifier Type: -
Identifier Source: org_study_id