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 UMIN000010361
Receipt No. R000012121
Scientific Title Surgical treatment of liver metastasis from gastric cancer: A retrospective cohort study (KSCC1302)
Date of disclosure of the study information 2013/03/29
Last modified on 2015/09/29

* 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 Surgical treatment of liver metastasis from gastric cancer: A retrospective cohort study (KSCC1302)
Acronym Surgical treatment of liver metastasis from gastric cancer: A retrospective cohort study (KSCC1302)
Scientific Title Surgical treatment of liver metastasis from gastric cancer: A retrospective cohort study (KSCC1302)
Scientific Title:Acronym Surgical treatment of liver metastasis from gastric cancer: A retrospective cohort study (KSCC1302)
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Multi-center retrospective cohort study for surgical resection of liver limited metastasis from gastric cancer.
To investigate the present situation of surgical resection of liver limited metastasis from gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression Free Survival
Prognostic factor of surgical treatment of liver metastasis

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Both primary tumor and liver metastasis were confirmed gastric adenocarcinoma histologically.
2)Metastases were limited in liver regardless of metachronous or synchronous.
3)Surgical treatment was performed from 2000/1/1 to 2010/3/31.
4)Primary tumor was resected.
Key exclusion criteria 1)Active or history of distant metastasis.(including the history of liver metastasis from gastric cancer)
2)Active or history of other malignancies.
Following cases were appropriate regardless of the other malignancy,
-Carcinoma in situ of cervical cancer.
-Focal cancer in colon adenoma.
-Synchronous double gastric cancer.
-History of gastric cancer resected with endoscopically according to the Japanese Gastric Cancer Guideline 3rd Edition.
-Five or more than 5 years have passed since previous gastric cancer treatment.
3)Not appropriate for the study at the physician's assessment.
Target sample size

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Maehara
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Surgery and Science
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL 092-631-2920
Email kscc2@cres-kyushu.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name KSCC
Organization Clinical Research Support Center Kyushu
Division name KSCC Research Secretariat
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL 092-631-2920
Homepage URL
Email kscc2@cres-kyushu.or.jp

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
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 九州大学(福岡県)、国立病院機構九州医療センター(福岡県)、国立病院機構九州がんセンター(福岡県)、済生会福岡総合病院(福岡県)、久留米大学(福岡県)、久留米大学医療センター(福岡県)、佐世保市立総合病院(長崎県)、熊本大学(熊本県)、健康保険人吉総合病院(熊本県)、大分赤十字病院(大分県)、国立病院機構別府医療センター(大分県)、中津市立中津市民病院(大分県)、鹿児島大学(鹿児島県)、琉球大学(沖縄県)、松山赤十字病院(愛媛県)、伊万里有田共立病院(佐賀県)、神戸市立医療センター 中央市民病院(兵庫県)、九州大学病院別府病院(大分県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective cohort study

Management information
Registered date
2013 Year 03 Month 29 Day
Last modified on
2015 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012121

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.