UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034035
Receipt number 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 10:02:29

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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 or person

Institute

National Cancer Center

Institute

Department

Personal name



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

Value
https://center6.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