Stage I Bladder CancerPhase 2NCT00666562
Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer
A Phase 2 study testing Defined Green Tea Catechin Extract, Laboratory Biomarker Analysis and Pharmacological Study in people with Stage I Bladder Cancer and Stage II Bladder Cancer, run by National Cancer Institute (NCI) at 6 sites in United States.
Trial summary
Green tea extract contains ingredients that may slow the growth of certain cancers. It is not yet known whether green tea extract is more effective than a placebo when given before surgery in treating patients with bladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Bladder Cancer, Stage II Bladder Cancer, Stage III Bladder Cancer
- What is being tested?
- Defined Green Tea Catechin Extract, Laboratory Biomarker Analysis and Pharmacological Study
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Jul 2008to 9 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Criteria:
- Diagnosis of bladder cancer
- Bladder tumor discovered on cystoscopy within the past 60 days
- Invasive or non-invasive tumor
- Primary tumor may represent either an initial diagnosis or recurrent disease of any clinical stage
- No metastatic disease
- Must be an eligible candidate for a partial cystectomy, radical cystectomy, or trans-urethral resection of bladder tumor (TURBT)
- Has not undergone any treatment for superficial or invasive bladder cancer since the diagnostic cystoscopy
- TURBT or radical cystectomy is the planned curative surgical treatment
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- More than 30 days since any prior intravesical therapy or adjuvant chemotherapy
- More than 30 days since prior bladder surgery
- Biopsies are not considered surgeries
- No prior pelvic radiotherapy
- No concurrent systemic chemotherapy for any other cancer, except nonmelanoma skin cancer
- No concurrent NSAIDs (e.g., ibuprofen, naproxen, or cyclooxygenase-2 inhibitors) except =< 81 mg aspirin per day
- Concurrent acetaminophen (Tylenol) or prescription opioids combined with acetaminophen (i.e., Percocet, Darvocet, Vicodin, Tylenol #3) allowed for pain
- No other concurrent investigational agents
- White Blood Cell (WBC) >= 3,000/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 10 g/dL
- Alkaline phosphatase =< upper limit of normal (ULN)
- Bilirubin =< ULN
- Asparate Aminotransferase (AST) and Alanine Transaminase (ALT) =< ULN
- Sodium 135-144 mmol/L (inclusive)
- Potassium 3.2-4.8 mmol/L (inclusive)
- Chloride 85-114 mmol/L (inclusive)
- Bicarbonate >11 mEQ/dL
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to avoid green tea beverages and green tea-containing products during study participation
- No evidence of other cancers, except nonmelanoma skin cancer
- No history of allergic reactions attributed to tea or to any of the compounds of similar chemical or biologic composition to Polyphenon E or any of the inactive ingredients in Polyphenon E capsules
- No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris, Cardiac arrhythmia, Psychiatric illness/social situations that would limit study compliance
- More than 24 hours since prior and no concurrent consumption of any other green tea supplements or more than 2 cups (16 oz) of green tea either through dietary sources or through nutritional supplementation
- Topical cosmetics (i.e., lotions, shampoos, makeup) that contain green tea are allowed
- Creatinine normal
- Not pregnant or nursing
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Minneapolis Veterans Medical Center
Minneapolis, Minnesota, 55417
University of Rochester
Rochester, New York, 14642
Urology San Antonio Research PA
San Antonio, Texas, 78229
About this study
Official title: A Phase II Randomized, Placebo-Controlled Trial of Polyphenon E to Evaluate Bladder Tissue Levels of EGCG
Green tea extract contains ingredients that may slow the growth of certain cancers. It is not yet known whether green tea extract is more effective than a placebo when given before surgery in treating patients with bladder. This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo when given before surgery in treating patients with nonmetastatic bladder cancer.
Read the detailed description
PRIMARY OBJECTIVES I. To compare the levels of epigallocatechin-3-gallate (EGCG) in nonmalignant bladder tissue from patients with bladder cancer treated with oral polyphenon E 800 mg EGCG or polyphenon E 1200 mg EGCG once daily for 14-28 days.
SECONDARY OBJECTIVES:
- To compare the levels of EGCG in nonmalignant versus malignant bladder tissue samples from these patients.
II. To examine the dose-response modulation of surrogate intermediate endpoint biomarkers (e.g., Proliferating Cell Nuclear Antigen [PCNA], Matrix Metallopeptidase 2 [MMP2], clusterin, Vascular endothelial Growth Factor [VEGF], p27, and ODC) in malignant and nonmalignant samples of bladder tissue from these patients after administration of polyphenon E.
III. To correlate EGCG levels in samples of serum, urine, and tissue from these patients.
IV. To examine the levels of other catechins (i.e., epicatechin, epicatechin gallate, and epigallocatechin) found in polyphenon E in samples of serum, urine, and tissue from these patients.
- To compare the metabolism of EGCG by Catechol-O-Methyltransferase (COMT) and Uridinediphosphate-Glucuronosyltransferase (UGT) in relation to pharmacogenetic polymorphisms in COMT and UGT in samples of serum, urine, and tissue from these patients.
VI. To examine the changes in serum Insulin Growth Factor 1 (IGF-1) and IGFBP-3 levels after administration of polyphenon E in these patients.
OUTLINE:
This is a multicenter study. Patients are stratified according to tumor site and disease invasiveness (invasive vs noninvasive). Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive six oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.
Arm II: Patients receive four oral polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.
Arm III: Patients receive six oral polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity.
After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
Blood, urine, and tissue samples are obtained at baseline and at the end of study treatment for correlative laboratory studies. Samples are evaluated for pharmacokinetics of polyphenon E using high performance liquid chromatography. Levels of epigallocatechin-3-gallate [EGCG] and other catechins found in polyphenon E are assessed for correlation in serum, urine, and tissue. Intermediate endpoint biomarkers are evaluated for dose-response modulation in serum (i.e., IGF-1 and IGFBP-3) via ELISA and in bladder tissue obtained at the time of bladder surgery (i.e., PCNA, MMP2, clusterin, VEGF, p27, and ODS) via IHC. Patients at the University of Wisconsin undergo additional biopsy of bladder tissue for matrix-assisted laser desorption quadrupole time-of-flight (O-MALDI-qTOF) analysis of EGCG pharmacokinetics. Tissue samples are examined for intracellular concentration and distribution of EGCG. Genotyping studies for pyrosequencing of UGT and COMT polymorphisms are also performed.
- Being tested
- Defined Green Tea Catechin Extract, Laboratory Biomarker Analysis, Pharmacological Study, Placebo, Therapeutic Conventional Surgery
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defined Green Tea Catechin ExtractDietary supplement
Also called Polyphenon E, Polyphenon E TM
Given orally
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
PlaceboDrug
Also called placebo therapy, PLCB, sham therapy
Given orally
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm I (placebo) | Placebo comparator | Patients receive six oral placebo capsules once daily for 14-28 days. Receives: Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Placebo |
| Arm II (polyphenon E, placebo) | Experimental | Patients receive four oral polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity. Receives: Dietary Supplement: Defined Green Tea Catechin Extract; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Placebo |
| Arm III (polyphenon E, trans-urethral resection or cystectomy) | Experimental | Patients receive six oral polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy. Receives: Dietary Supplement: Defined Green Tea Catechin Extract; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors)
Comparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.
Measured: up to 28 days
Secondary outcomes (12)
Levels of EGCG in Malignant Bladder Tissue
Measured: up to 28 days
Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry
Measured: up to 28 days
Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA
Measured: Baseline and up to day 28
Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples
Measured: up to 28 days
Absolute Change for Baseline From EGCG in Serum Samples
The difference between the amount at the end of study (up to 28 days) from baseline.
Measured: Baseline and up to 28 days
Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT)
Measured: At Baseline
Serum IGFBP-3 Levels Assessed by ELISA
Measured: Baseline and up to 28 days
Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples
Measured: up to 28 days
Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples
The difference between the amount at the end of study (up to 28 days) from baseline.
Measured: Baseline and up to 28 days
Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples
The difference between the amount at the end of study (up to 28 days) from baseline.
Measured: Baseline and up to 28 days
Absolute Change for Baseline of EGCG in Urine Samples
The difference between the amount at the end of study (up to 28 days) from baseline.
Measured: Baseline and up to 28 days
Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT)
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study start2 Jul 2008
- Primary completion26 Apr 2012
- Study completion9 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage I Bladder CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tracy Downs, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666562
- Sponsor's protocol ID
- NCI-2009-00906
- Other IDs
- NCI-2009-00906, CO06810, CDR0000594276, H-2007-0250, UWI06-8-01, UWI06-8-01, N01CN35153, P30CA014520
- Status last verified
- Oct 2017
- First submitted
- 24 Apr 2008
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Placebo-Controlled Trial of Polyphenon E to Evaluate Bladder Tissue Levels of EGCG
- ClinicalTrials.gov ID
- NCT00666562
- Acronym / sponsor ID
- NCI-2009-00906
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 2 Jul 2008 (actual)
- Primary completion
- 26 Apr 2012 (actual)
- Study completion
- 9 Jun 2017 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Posted 28 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Green tea extract contains ingredients that may slow the growth of certain cancers. It is not yet known whether green tea extract is more effective than a placebo when given before surgery in treating patients with bladder. This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo when given before surgery in treating patients with nonmetastatic bladder cancer.
Detailed description
PRIMARY OBJECTIVES I. To compare the levels of epigallocatechin-3-gallate (EGCG) in nonmalignant bladder tissue from patients with bladder cancer treated with oral polyphenon E 800 mg EGCG or polyphenon E 1200 mg EGCG once daily for 14-28 days.
SECONDARY OBJECTIVES:
- To compare the levels of EGCG in nonmalignant versus malignant bladder tissue samples from these patients.
II. To examine the dose-response modulation of surrogate intermediate endpoint biomarkers (e.g., Proliferating Cell Nuclear Antigen [PCNA], Matrix Metallopeptidase 2 [MMP2], clusterin, Vascular endothelial Growth Factor [VEGF], p27, and ODC) in malignant and nonmalignant samples of bladder tissue from these patients after administration of polyphenon E.
III. To correlate EGCG levels in samples of serum, urine, and tissue from these patients.
IV. To examine the levels of other catechins (i.e., epicatechin, epicatechin gallate, and epigallocatechin) found in polyphenon E in samples of serum, urine, and tissue from these patients.
- To compare the metabolism of EGCG by Catechol-O-Methyltransferase (COMT) and Uridinediphosphate-Glucuronosyltransferase (UGT) in relation to pharmacogenetic polymorphisms in COMT and UGT in samples of serum, urine, and tissue from these patients.
VI. To examine the changes in serum Insulin Growth Factor 1 (IGF-1) and IGFBP-3 levels after administration of polyphenon E in these patients.
OUTLINE:
This is a multicenter study. Patients are stratified according to tumor site and disease invasiveness (invasive vs noninvasive). Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive six oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.
Arm II: Patients receive four oral polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.
Arm III: Patients receive six oral polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity.
After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
Blood, urine, and tissue samples are obtained at baseline and at the end of study treatment for correlative laboratory studies. Samples are evaluated for pharmacokinetics of polyphenon E using high performance liquid chromatography. Levels of epigallocatechin-3-gallate [EGCG] and other catechins found in polyphenon E are assessed for correlation in serum, urine, and tissue. Intermediate endpoint biomarkers are evaluated for dose-response modulation in serum (i.e., IGF-1 and IGFBP-3) via ELISA and in bladder tissue obtained at the time of bladder surgery (i.e., PCNA, MMP2, clusterin, VEGF, p27, and ODS) via IHC. Patients at the University of Wisconsin undergo additional biopsy of bladder tissue for matrix-assisted laser desorption quadrupole time-of-flight (O-MALDI-qTOF) analysis of EGCG pharmacokinetics. Tissue samples are examined for intracellular concentration and distribution of EGCG. Genotyping studies for pyrosequencing of UGT and COMT polymorphisms are also performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (placebo) | Placebo comparator | Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Drug: PlaceboPatients receive six oral placebo capsules once daily for 14-28 days. |
| Arm II (polyphenon E, placebo) | Experimental | Dietary Supplement: Defined Green Tea Catechin Extract, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Drug: PlaceboPatients receive four oral polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity. |
| Arm III (polyphenon E, trans-urethral resection or cystectomy) | Experimental | Dietary Supplement: Defined Green Tea Catechin Extract, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Procedure: Therapeutic Conventional SurgeryPatients receive six oral polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Defined Green Tea Catechin ExtractAlso: Polyphenon E, Polyphenon E TMGiven orally | Dietary supplement | Arm II (polyphenon E, placebo), Arm III (polyphenon E, trans-urethral resection or cystectomy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (placebo), Arm II (polyphenon E, placebo), Arm III (polyphenon E, trans-urethral resection or cystectomy) |
| Pharmacological StudyCorrelative studies | Other | Arm I (placebo), Arm II (polyphenon E, placebo), Arm III (polyphenon E, trans-urethral resection or cystectomy) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven orally | Drug | Arm I (placebo), Arm II (polyphenon E, placebo) |
| Therapeutic Conventional SurgeryUndergo surgery | Procedure or surgery | Arm III (polyphenon E, trans-urethral resection or cystectomy) |
Primary outcome
Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors)
Time frame: up to 28 days
Comparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.
12 secondary outcomes
Levels of EGCG in Malignant Bladder Tissue
Time frame: up to 28 days
Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry
Time frame: up to 28 days
Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA
Time frame: Baseline and up to day 28
Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples
Time frame: up to 28 days
Absolute Change for Baseline From EGCG in Serum Samples
Time frame: Baseline and up to 28 days
Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT)
Time frame: At Baseline
Serum IGFBP-3 Levels Assessed by ELISA
Time frame: Baseline and up to 28 days
Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples
Time frame: up to 28 days
Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples
Time frame: Baseline and up to 28 days
Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples
Time frame: Baseline and up to 28 days
Absolute Change for Baseline of EGCG in Urine Samples
Time frame: Baseline and up to 28 days
Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT)
Time frame: At Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tracy Downs principal investigator
University of Wisconsin, Madison
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Defined Green Tea Catechin Extract, Laboratory Biomarker Analysis and Pharmacological Study in people with Stage I Bladder Cancer and Stage II Bladder Cancer, run by National Cancer Institute (NCI) at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors) (time frame: up to 28 days). 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 17 Nov 2017.