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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034035
Receipt No. R000038799
Scientific Title Pilot study of the usefulness of ALA for pimary colorectal cancer
Date of disclosure of the study information 2018/09/05
Last modified on 2020/03/07

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Basic information
Public title Pilot study of the usefulness of ALA for pimary colorectal cancer
Acronym ALA
Scientific Title Pilot study of the usefulness of ALA for pimary colorectal cancer
Scientific Title:Acronym ALA
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Search for identifiability and safety of tumors using ALA
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification ratio
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Administration of ALA
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Histologically proved to be colorectal cancer
Key exclusion criteria Allergy for Porphyrin
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yukihide
Middle name
Last name Kanemitsu
Organization National cancer center hospital
Division name Division of Colorectal Surgery
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 0335475201
Email ykanemit@ncc.go.jp

Public contact
Name of contact person
1st name Shunsuke
Middle name
Last name Tsukamoto
Organization National Cancer Center Hospital
Division name Division of Colorectal Surgery
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 0335475201
Homepage URL
Email shtsukam@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization National Cancer Center Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National cancer center
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel 0335475201
Email shtsukam@ncc.go.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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 05 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled 9
Results 
The tumor identification rate by ALA was found to be only 4 out of 9 cases, and it was found to be less than half in 10 cases, violating the discontinuation criteria. The usefulness of ALA in colorectal cancer was not clear.
Results date posted
2020 Year 03 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Colorectal cancer
Participant flow 
Preoperative registration
Adverse events 
none
Outcome measures 
Inactive cancellation
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 07 Month 14 Day
Date of IRB
2016 Year 10 Month 28 Day
Anticipated trial start date
2017 Year 01 Month 03 Day
Last follow-up date
2019 Year 02 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 05 Day
Last modified on
2020 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038799

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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