UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042244 |
|---|---|
| Receipt number | R000048184 |
| Scientific Title | Prospective Multicenter Observational Study of Conversion Surgery for Advanced Gastric Cancer |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2021/01/19 23:07:43 |
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Basic information
Public title
Prospective Multicenter Observational Study of Conversion Surgery for Advanced Gastric Cancer
Acronym
Prospective Multicenter Observational Study of Conversion Surgery for Advanced Gastric Cancer
Scientific Title
Prospective Multicenter Observational Study of Conversion Surgery for Advanced Gastric Cancer
Scientific Title:Acronym
Prospective Multicenter Observational Study of Conversion Surgery for Advanced Gastric Cancer
Region
| Japan |
Condition
Condition
Advanced gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the incidence and outcomes of conversion surgery for advanced gastric cancer
Basic objectives2
Others
Basic objectives -Others
To elucidate the incidence and outcomes of conversion surgery for advanced gastric cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients undergo conversion surgery in advanced gastric cancer
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Clinical stage IVB gastric cancer.
2)Patients who will receive chemotherapy.
3)Histologically diagnosed as gastric adenocarcinoma.
4)Length of esophageal invasion not exceeding 4 cm.
5)Aged between 20 and 79 years old.
6)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
7)Obtained informed consent.
Key exclusion criteria
1)Synchronous or metachronous (within 5 years) malignancies.
2)Inappropriate judged by the investigators.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2250
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Nakanishi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2250
Homepage URL
konakani@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2061
ethics@med.nagoya-u.ac.jp
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
| 2020 | Year | 12 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-center collaborative study
Management information
Registered date
| 2020 | Year | 10 | Month | 26 | Day |
Last modified on
| 2021 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048184
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
