UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031060 |
|---|---|
| Receipt number | R000035327 |
| Scientific Title | Prognostic and effect predictive factors of multimodality treatment for gastric cancer |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2018/04/11 15:24:58 |
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Basic information
Public title
Prognostic and effect predictive factors of multimodality treatment for gastric cancer
Acronym
Prognostic and effect predictive factors of multimodality treatment for gastric cancer
Scientific Title
Prognostic and effect predictive factors of multimodality treatment for gastric cancer
Scientific Title:Acronym
Prognostic and effect predictive factors of multimodality treatment for gastric cancer
Region
| Japan | South America |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the research is to clarify the prognostic end effect predictive factors of multimodality treatment for the patients with gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Recurrence rate
Progression free survival
Overall objective response rate
Side effects of chemotherapy
perioperative complication
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Gastric cancer
Key exclusion criteria
Patients with poorer prognosis less than three months. Patients who decline the offer to use the data
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masazumi Takahashi |
Organization
Yokohama Municipal Citizen's Hospital
Division name
Division of Gastroenterological Surgery
Zip code
Address
Okazawa-cho 56, hodogaya-ku, Yokohama
TEL
045-331-1961
ma06-takahashi@city.yokohama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masazumi Takahashi |
Organization
Yokohama Municipal Citizen's Hospital
Division name
Division of Gastroenterological Surgery
Zip code
Address
Okazawa-cho 56, hodogaya-ku, Yokohama
TEL
045-331-1961
Homepage URL
ma06-takahashi@city.yokohama.jp
Sponsor or person
Institute
Yokohama Municipal Citizen's Hospital, Division of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
Yokohama Municipal Citizen's Hospital
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
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
横浜市立市民病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cohort study. Patients who were diagnosed as gastric cancer from 1999/4/1 to 2024/3/31 are calculated to this study. The endpoints are as follows.
1. Treatment (chemotherapy only, chemotherapy after operation, operation after chemotherapy, with of without radiation therapy)
2. Death investigation (date of death, cause of death)
3. Selected chemotherapy and numbers of course
4. Side-effects of chemotherapy according to the CTCAE guidelines.(RBC, Hb, WBC, Plt, TP, Alb, AST, ALT, gamma GTP, BUN, Crt %lymphocte, %monocyte
5. Prognostic and effect predictive factors, %lymphocte, %monocyte, %neutrocte, Number of Plt, CRP, sIL-2R, Alb
6. Timing of operation and operation method
7. Operative complications according to the Clavien-Dindo classification.
Management information
Registered date
| 2018 | Year | 01 | Month | 30 | Day |
Last modified on
| 2018 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035327
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
