UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030531 |
|---|---|
| Receipt number | R000034853 |
| Scientific Title | The study on laparoscopic diagnosis of peritoneal dissemination of colorectal cancer with 5-aminolevulinic acid |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/06/25 09:30:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
maeda.fumi@twmu.ac.jp
Sponsor or person
Institute
The department of surgery, Institute of gastroenterology, Tokyo Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034853
