UMIN-CTR Clinical Trial

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

Bladder cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The University of Texas MD Anderson Cancer Center

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

We found that folic acid and natural folate had differential impact on clinical outcomes in non-muscle-invasive bladder cancer patients.

Registered date

2017

Year

06

Month

03

Day

Last modified on

2017

Year

12

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031644