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

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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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034853


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name