UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014461
Receipt No. R000016824
Scientific Title The study on the usefulness of fucoidan-containing food intake for early or unresectable advanced gastric cancer patients
Date of disclosure of the study information 2014/09/01
Last modified on 2017/07/04

* 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 the usefulness of fucoidan-containing food intake for early or unresectable advanced gastric cancer patients
Acronym The study on the usefulness of fucoidan intake for gastric cancer patients
Scientific Title The study on the usefulness of fucoidan-containing food intake for early or unresectable advanced gastric cancer patients
Scientific Title:Acronym The study on the usefulness of fucoidan intake for gastric cancer patients
Region
Japan

Condition
Condition early or unresectable advanced gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the effects on immune function and so on by intaking food including fucoidan for early gastric cancer patients or unresectable advanced gastric cancer patients with the standard chemotherapy as first-line treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess immune monitoring such as cytokines, QOL evaluation and intestinal flora analysis.
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 Treatment
Type of intervention
Food
Interventions/Control_1 To intake fucoidan-containing food every day.
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) Histologically confirmed gastric cancer.
2) Patients informed diagnosis of their disease.
3) Aged from 20 over years.
4) Grade 0 to 2 in performance status (ECOG).
5) In early gastric cancer patients, patients with confirmed the curative resection with endoscopic treatment.
6) In advanced gastric cancer patients, patients who are scheduled to newly primary chemotherapy.
7) Expected to be alive at least six months after informed consent in advanced gastric cancer patients.
8) Having written informed consent.
Key exclusion criteria 1) Presence of severe complications (heart failure, liver desease, renal desease).
2) Presence of infectious disease.
3) Taking the drug affecting immune system such as steroid and immunosuppresant.
4) Taking the supplement affecting immune system.
5) Inappropriate patients for study judged by the physicians.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5519
Homepage URL
Email ynaito@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor TAKARA BIO, INC
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 京都府立医科大学附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2014 Year 09 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
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 02 Day
Last modified on
2017 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016824

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.