UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014461 |
|---|---|
| Receipt number | 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 18:11:57 |
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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
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
ynaito@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
