UMIN-CTR Clinical Trial

Basic information
Public title	The study on laparoscopic diagnosis of peritoneal dissemination of colorectal cancer with 5-aminolevulinic acid
Acronym	The study on laparoscopic diagnosis of peritoneal dissemination of colorectal cancer with 5-ALA
Scientific Title	The study on laparoscopic diagnosis of peritoneal dissemination of colorectal cancer with 5-aminolevulinic acid
Scientific Title:Acronym	The study on laparoscopic diagnosis of peritoneal dissemination of colorectal cancer with 5-ALA
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to clarify whether photodynamic diagnosis by 5-aminolevulinic acid is useful for diagnosis of peritoneal dissemination of colorectal cancer in laparoscopic surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Phase I

Assessment
Primary outcomes	Positive predictive value in intraoperative photodynamic diagnosis using 5 aminolevulinic acid in colorectal peritoneal dissemination
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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	5 Aminolevulinic acid
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Target patients who satisfy all of the following criteria 1, Patients who are visiting or hospitalized to the department of gastrointestinal surgery of Tokyo Medical University hospital 2, Male and female aged 20 years and over 3,Patients diagnosed with colorectal cancer excluding lower rectal cancer 4, Patients planned to undergo laparoscopic colorectal surgery 5, Patients who have high possibility of peritoneal dissemination by clinical and preoperative imaging 6,Patients with the tumor, the depth is diagnosed deeper than submucosa 7, After receiving sufficient explanation for participation in this research, patients who gained written consent with sufficient understanding
Key exclusion criteria	1,Pregnant women or breast-feeding patients. 2,Patients whom research managers judged inappropriate as subjects 3,Patients who have light hypersensitivity, history of porphyria, or family history.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masakazu Yamamoto
Organization	Tokyo Women's Medical University
Division name	Department of surgery, Institute of gastroenterology
Zip code
Address	8-1, Kawada-cho, Shinjyuku-ku, Tokyo
TEL	03-3353-8111
Email	yamamoto.ige@twmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Fumi Maeda
Organization	Tokyo Women's Medical University
Division name	Department of surgery, Institute of gastroenterology
Zip code
Address	8-1, Kawada-cho, Shinjyuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	maeda.fumi@twmu.ac.jp

Sponsor
Institute	The department of surgery, Institute of gastroenterology, Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization	5 Aminolevulinic acid used for this research provided free of charge by SBI pharma
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
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	東京女子医科大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 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	2017 Year 04 Month 08 Day
Date of IRB	2018 Year 03 Month 31 Day
Anticipated trial start date	2017 Year 12 Month 18 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 22 Day
Last modified on	2021 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034853