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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027617
Receipt No. R000031644
Scientific Title Intake of synthetic versus natural folate and clinical outcomes in non-muscle-invasive bladder cancer
Date of disclosure of the study information 2017/06/03
Last modified on 2017/12/03

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Basic information
Public title Intake of synthetic versus natural folate and clinical outcomes in non-muscle-invasive bladder cancer
Acronym Folate intake and treatment outcomes in early stage bladder cancer patients
Scientific Title Intake of synthetic versus natural folate and clinical outcomes in non-muscle-invasive bladder cancer
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Dr. Huakang Tu
Organization The University of Texas MD Anderson Cancer
Center
Division name Division of Cancer Prevention & Population Sciences
Zip code
Address 1155 Pressler Street, Houston, TX, USA, 77030
TEL 7137456699
Email htu2@mdanderson.org

Public contact
1st name of contact person
1st name
Middle name
Last name Dr. Huakang Tu
Organization The University of Texas MD Anderson Cancer Center
Division name Division of Cancer Prevention & Population Sciences
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
1996 Year 10 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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