UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044817 |
|---|---|
| Receipt number | R000051179 |
| Scientific Title | Prospective observational study for the safety and efficacy of chemotherapy in gastric cancer |
| Date of disclosure of the study information | 2021/07/09 |
| Last modified on | 2021/07/09 15:50:45 |
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Basic information
Public title
Prospective observational study for the safety and efficacy of chemotherapy in gastric cancer
Acronym
Prospective study for the chemotherapy in gastric cancer
Scientific Title
Prospective observational study for the safety and efficacy of chemotherapy in gastric cancer
Scientific Title:Acronym
Prospective study for the chemotherapy in gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the reality of chemotherapy in gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival (OS) and the contributing factors associated with OS
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Inpatients and outpatients who were diagnosed gastric cancer and receive chemotherapy from the permission of ethics committee to March 31,2026.
2. Patients who can offer written informed consent
3. Patients with 20 years and over
Key exclusion criteria
1. Patients who are not suitable for chemotherapy
2. Patients who reject chemotherapy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Toshiyoshi |
| Middle name | |
| Last name | Fujiwara |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterological Surgery
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama City
TEL
086-235-7257
toshi_f@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyasu |
| Middle name | |
| Last name | Kono |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama City
TEL
086-235-7219
Homepage URL
hxnwq178@yahoo.co.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama City
Tel
086-235-6938
mae6605@adm.okayama-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
| 2021 | Year | 07 | Month | 09 | 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
| 2021 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
Advanced and unresectable gastric cancer or resectable gastric cancer patients who receive chemotherapy or adjuvant chemotherapy are included. Clinical data about patient background and treatment(age, sex, types of regimen, treatment start date, stage, performance status, HER2 status, metastasis cite,and laboratory data, treatment end date, adverse effect, best response, and resection of primary lesion) are collected.
Management information
Registered date
| 2021 | Year | 07 | Month | 09 | Day |
Last modified on
| 2021 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051179
| 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 |
