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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031060
Receipt No. 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

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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
Email 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
Email ma06-takahashi@city.yokohama.jp

Sponsor
Institute Yokohama Municipal Citizen's Hospital, Division of Gastroenterological Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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