UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010361 |
|---|---|
| Receipt number | 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 21:57:10 |
* 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
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
kscc2@cres-kyushu.or.jp
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer
Institute
Department
Personal name
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
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
Value
https://center6.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 |
