UMIN-CTR Clinical Trial

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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