UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intake of synthetic versus natural folate and clinical outcomes in non-muscle-invasive bladder cancer
Title of the study (Brief title)	Folate intake and treatment outcomes in early stage bladder cancer patients
Region	North America

Condition
Condition	Bladder cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Folic acid (synthetic folate) from supplements or fortification has different metabolic pathways than natural folate and may promote cancer growth especially among those with neoplastic alterations. Therefore, we for the first time investigated the prospective association of intake of folic acid and natural folate at diagnosis with risk of recurrence and progression among a large clinical cohort of non-muscle-invasive bladder cancer patients.
Basic objectives2	Others
Basic objectives -Others	Associations between folate intake and clinical outcomes in bladder cancer
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Tumor recurrence was defined as a newly found bladder tumor during follow-up, and progression was defined as the transition from non-muscle-invasive to invasive or metastatic disease during follow-up.
Key secondary outcomes	Stratified associations by treatments. Folate intake and five tumor characteristics at diagnosis: focality, size, grade, stage, and concomitant carcinoma in situ.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Non-muscle-invasive bladder (Ta, Tis, and T1) patients who were newly diagnosed (within 1 year before recruitment) between 1997 and 2012, with histologic confirmation, and were previously untreated with chemotherapy or radiotherapy. For the present study, we limited the analysis to non-Hispanic whites who account for the majority of the study population.
Key exclusion criteria	Patients with outlying (i.e., outside the interval delimited by the 25th percentile minus 1.5 times the interquartile range and the 75th percentile plus 1.5 times the interquartile range) or implausible (i.e., <500 kcal/d or >5,000 kcal/d) energy intakes.
Target sample size	600

Research contact person
Name of lead principal investigator	Dr. Huakang Tu
Organization	The University of Texas MD Anderson Cancer Center
Division name	Division of Cancer Prevention & Population Sciences
Address	1155 Pressler Street, Houston, TX, USA, 77030
TEL	7137456699
Email	htu2@mdanderson.org

Public contact
Name of contact person	Dr. Huakang Tu
Organization	The University of Texas MD Anderson Cancer Center
Division name	Division of Cancer Prevention & Population Sciences
Address	1155 Pressler Street, Houston, TX, USA, 77030
TEL	7137456699
Homepage URL
Email	htu2@mdanderson.org

Sponsor
Institute	The University of Texas MD Anderson Cancer Center
Institute
Department

Funding Source
Organization	National Cancer Institute at the National Institutes of Health (P50 CA 91846) and Center for Translational and Public Health Genomics at MD Anderson Cancer Center.
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	USA

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	1996 Year 10 Month 01 Day
Anticipated trial start date	1997 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We found that folic acid and natural folate had differential impact on clinical outcomes in non-muscle-invasive bladder cancer patients.

Management information
Registered date	2017 Year 06 Month 03 Day
Last modified on	2017 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031644