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Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma

Primary Purpose

Carcinoma, Transitional Cell

Status
Withdrawn
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Lycopene
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carcinoma, Transitional Cell focused on measuring Urothelial carcinoma, Lycopene, uremia, prevention, biomarker, progression, anti-oxidant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • National Taiwan University Hospital

Outcomes

Primary Outcome Measures

changes of intermediate biomarker status after lycopene supplementation

Secondary Outcome Measures

safety and tolerability

Full Information

First Posted
September 12, 2005
Last Updated
September 25, 2008
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00172367
Brief Title
Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2004
Overall Recruitment Status
Withdrawn
Why Stopped
This study was for National Science Council project. The study was not funded, so the study was withdrawn.
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Transitional Cell
Keywords
Urothelial carcinoma, Lycopene, uremia, prevention, biomarker, progression, anti-oxidant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lycopene
Primary Outcome Measure Information:
Title
changes of intermediate biomarker status after lycopene supplementation
Secondary Outcome Measure Information:
Title
safety and tolerability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeong-Shiau Pu, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma

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