UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029926 |
|---|---|
| Receipt number | R000034146 |
| Scientific Title | The efficacy of Leukotriene receptor antagonist for human rectal aberrant crypt foci: nonrandomized open label controlled trial |
| Date of disclosure of the study information | 2017/11/13 |
| Last modified on | 2024/12/11 20:46:45 |
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Basic information
Public title
The efficacy of Leukotriene receptor antagonist for human rectal aberrant crypt foci: nonrandomized open label controlled trial
Acronym
The efficacy of LTRA for human ACF
Scientific Title
The efficacy of Leukotriene receptor antagonist for human rectal aberrant crypt foci: nonrandomized open label controlled trial
Scientific Title:Acronym
The efficacy of LTRA for human ACF
Region
| Japan |
Condition
Condition
Patients with both colorectal ACF and resectable polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the chemopreventive effect of LTRA against the rectal ACF
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The amount of change rectal ACF in LTRA group and control group after 8weeks intervention
Key secondary outcomes
The number of rectal ACF before and after intervention in both group
Ki67 labeling index of colorectal adnoema/cancer and normal mucosa before and after intervention
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
receive Montelukast 10mg for 8 weeks
Interventions/Control_2
no treatment observation
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with resectable polyps.
2.Patients with more than 5 rectal ACF
3.Willingness to provide written informed consent
Key exclusion criteria
1.Patients with lesion which preferred early resection.
2.History of use of LTRA within 2months before trial entry.
3.History of malignant disease within 5 yeears before trial entry.
4.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure
5.History of familial adenomatous polyposis, hereditary non-polyposis colorectal cancer and inflammatory bowel disease
6.Pregnancy or possibility of pregnancy
7.Contraindication to Montelukast
8.Allergy to Montelukast
9.Regular use of NSAIDs, metformin, piogrlitazone
10.Patients judged as inappropriate candidates for the trial by the investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa, Yokohama, Kanagawa
TEL
045-787-2640
takuma_h@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa, Yokohama, Kanagawa
TEL
045-787-2640
Homepage URL
takuma_h@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Institute of Industrial Science and Technology
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital IRB
Address
3-9 Fukuura Kanazawa-ku Yokohama City
Tel
81-45-787-2640
takuma_h@yokohama-cu.ac.jp
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
n/a
Publication of results
Published
Result
URL related to results and publications
https://aacrjournals.org/cancerpreventionresearch/article/15/10/661/709276/Leukotriene-Receptor-Anta
Number of participants that the trial has enrolled
40
Results
LTRA decreased rectal ACF
Results date posted
| 2022 | Year | 11 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 06 | Month | 20 | Day |
Baseline Characteristics
Patients with colorectal neoplasm and ACF
Participant flow
Comparison of ACF counts before and after 2 months of treatment or follow-up with a leukotriene receptor antagonist in patients with ACF and colorectal neoplasm
Adverse events
None
Outcome measures
rectal ACF
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 10 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034146
