UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025541
Receipt No. R000029399
Scientific Title The phase II study to clarify the usefulness of swallow ability test and pneumonia prediction program in elderly patients with gastric cancer
Date of disclosure of the study information 2017/01/05
Last modified on 2017/01/05

* 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 phase II study to clarify the usefulness of swallow ability test and pneumonia prediction program in elderly patients with gastric cancer
Acronym Pneumonia prediction in elderly patients with gastric cancer
Scientific Title The phase II study to clarify the usefulness of swallow ability test and pneumonia prediction program in elderly patients with gastric cancer
Scientific Title:Acronym Pneumonia prediction in elderly patients with gastric cancer
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 the aim of thie single-center prospective phase II study was to clarify the usefulnesss of swallow ability screening and pneumonia prediction program for elderly patients with gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of postoperative pneumonia
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 NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 wallow ability screening and pneumonia prediction program
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) histologically confirmed adenocarcinoma
of the stomach
2) sufficient oral intake
3) patient age of 75 years or more
4) an Eastern Cooperative Oncology
Group performance status of 0-1
5) no prior chemotherapy or radiotherapy
for any malignancy
6) adequate organ function
7) written informed consent.
Key exclusion criteria 1) with infection conditions
2) with mental disease
3) patients who take systemic steroid therapy
4) patients who take insulin therapy
Target sample size 85

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Terashima
Organization Shizuoka Cancer Center
Division name Gastric Surgery
Zip code
Address 1007, Shimonagakubo, Nagaizumi, Suntogun, Shizuoka
TEL 055-989-5222
Email m.terashima@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichiro MIki
Organization Osaka City University
Division name Surgical Oncology
Zip code
Address 1-4-3, Asahimachi, Abenoku, Osaka
TEL 0666452121
Homepage URL
Email y_miki@med.osaka-cu.ac.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Shizuoka Cancer Center
Organization
Division
Category of Funding Organization Local Government
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 05 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 No longer recruiting
Date of protocol fixation
2015 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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
2017 Year 01 Month 05 Day
Last modified on
2017 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029399

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.