UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039304
Receipt number R000044829
Scientific Title Study on cancer risk assessment method using 5-aminolevulinic acid
Date of disclosure of the study information 2020/01/29
Last modified on 2024/02/01 09:02:21

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Basic information

Public title

Study on cancer risk assessment method using 5-aminolevulinic acid

Acronym

cancer risk assessment method using 5-aminolevulinic acid

Scientific Title

Study on cancer risk assessment method using 5-aminolevulinic acid

Scientific Title:Acronym

cancer risk assessment method using 5-aminolevulinic acid

Region

Japan


Condition

Condition

Lung cancer, colon cancer, stomach cancer, breast cancer

Classification by specialty

Surgery in general Gastrointestinal surgery Chest surgery
Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Cancer that causes metabolic dysfunction by taking 5-aminolevulinic acid phosphate and detecting porphyrins, that are not excreted as urinary metabolites if metabolic functions in normal cells, assess the degree of cancer risk.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

Analysis of the accuracy of 5-aminolevulinic acid as a cancer risk assessment index

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

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral administration of 5-aminolevulinic acid phosphate 150 mg once at night

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

1) Cancer patients 20 years or older (male, female)
2) Patients diagnosed with the target carcinoma (lung cancer, stomach cancer, colon cancer, breast cancer)
3) Patients who do not have different primary tumors other than the target 4 carcinomas
4) Patients whose target carcinoma is recognized by CT, MRI, ultrasound, etc.
5) Inpatients
6) Patients who have given written consent to participate in this study
7) Patients who have not been treated with high-concentration vitamin C therapy or hyperthermia, radiation, or other phototherapy combined with 5ALA in the period one month before urine collection
8) Patients who can stop drugs, supplements, drinking, smoking, etc. on the day of urine collection

Key exclusion criteria

1) Patients with a history or diagnosis of porphyria
2) Pregnant women or patients who may become pregnant or breastfeeding
3) Patients who have difficulty in filling in the consent form or have problems with the urine collection procedure due to psychiatric complications, etc.
4) Patients with primary tumors other than the target 4 carcinomas
5) Patients who underwent high-concentration vitamin C therapy or treatment with 5-ALA, such as heat, radiation, or other phototherapy, one month before urine collection
6) Patients with severe cardiovascular disease, lung, liver, or kidney disease who are undergoing treatment or are at risk for it
7) Patients who are required to prescribe drugs separately prescribed on the day of urine collection
8) Other patients who are judged inappropriate by the doctor's judgment

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Masafumi
Middle name
Last name Kawamura

Organization

Teikyo University School of medicine

Division name

Department of surgery

Zip code

173-8605

Address

Kaga 2-11-1, Itabashi, Tokyo, Japan

TEL

03-3964-1211

Email

mkawamur@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name Yoshikane
Middle name
Last name Yamauchi

Organization

Teikyo University School of medicine

Division name

Department of surgery

Zip code

173-8605

Address

Kaga 2-11-1, Itabashi, Tokyo, Japan

TEL

03-3964-1211

Homepage URL


Email

yoshikaney@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo University School of medicine

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Teikyo University Ethics committee

Address

Kaga 2-11-1, Itabashi, Tokyo, Japan

Tel

03-3964-7256

Email

turb-office@teikyo-u.ac.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

2020 Year 01 Month 29 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

Enrolling by invitation

Date of protocol fixation

2018 Year 01 Month 16 Day

Date of IRB

2018 Year 01 Month 16 Day

Anticipated trial start date

2018 Year 05 Month 01 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 29 Day

Last modified on

2024 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044829


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name