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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037487
Receipt No. R000042735
Scientific Title Prospective observational study to develop the evaluation methods of the gastric cancer pathophysiology and the prediction methods of the anti-cancer therapy response.
Date of disclosure of the study information 2019/07/29
Last modified on 2020/02/12

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Basic information
Public title Prospective observational study to develop the evaluation methods of the gastric cancer pathophysiology and the prediction methods of the anti-cancer therapy response.
Acronym Clinical study to develop the prediction methods of the anti-cancer therapy response.
Scientific Title Prospective observational study to develop the evaluation methods of the gastric cancer pathophysiology and the prediction methods of the anti-cancer therapy response.
Scientific Title:Acronym Clinical study to develop the prediction methods of the anti-cancer therapy response.
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 1.To clear my doubts why such patients responded or not to anti-cancer drug exists. Does this base on their pathophysiology?
2.And to solve my hypothesis was that if a new patient who has an identical or similar HLA profile as another patient who has survived for a long time is given the same treatment or drug, that new patient might also survive for a long time.
3.Exploratory research of predictors for the effectiveness of therapy.
Basic objectives2 Others
Basic objectives -Others Exploratory research of predictors for the effectiveness of therapy.
Evaluation of QOL
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival and QOL based on predictors.
Key secondary outcomes HLA
APRs
Cellar immunity
QOL

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 Primary gastric cancer patients who gave informed consent and received the examination of HLA, APRs, cellular immunity, QOL questionnaire, and so on.
Patients refused to enroll in RCT or refuse to receive anti-cancer drugs, but want to receive some anti-cancer drugs selected by him/herself, or to HLA oriented therapy.
Drugs used were PSK,
F, MMC and CDDP.
Key exclusion criteria N/A
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Toshio
Middle name
Last name Mitomi
Organization Tokai University
Division name Department of Surgery
Zip code 259-1193
Address Bohseidai, Isehara, Kanagawa 259-1193, Japan.
TEL 0463-96-6163
Email ogoshi@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Kyoji
Middle name
Last name Ogoshi
Organization Tokai University
Division name Department of Surgery
Zip code 259-1193
Address Bohseidai, Isehara, Kanagawa 259-1193, Japan.
TEL 0463-96-6163
Homepage URL
Email ogoshi@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

Funding Source
Organization Tokai University
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 Tokai University
Address Bohseidai, Isehara, Kanagawa 259-1193, Japan.
Tel 0463-96-6163
Email ogoshi@is.icc.u-tokai.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 東海大学病院

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 29 Day

Related information
URL releasing protocol N/A
Publication of results Partially published

Result
URL related to results and publications http://joi.jlc.jst.go.jp/JST.JSTAGE/acrt/19.44?from=CrossRef
Number of participants that the trial has enrolled 878
Results
The correlation between CEA and APRs was possible to predict the efficacy of PSK combination therapy. 
Our results showed that patients with preoperative examination of HLA antigens were better survival than those without examination.
We, however, failed to find a specific HLA profile to treatment response. 
Results date posted
2019 Year 07 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male:Female=643:235
Median age (range): 60 years old (24-92 years old)
Participant flow
No. of patients given therapy 
Gastrectomy alone 378
PSK                 34
F                  124
FPSK               193
M                   53
MF                  55
MFPSK               35
CF                   7
CFPSK                1
Adverse events
Seven patients were died within 30 days after gastrectomy.
Outcome measures
Overall survival
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
1977 Year 09 Month 01 Day
Date of IRB
1977 Year 09 Month 01 Day
Anticipated trial start date
1977 Year 09 Month 12 Day
Last follow-up date
2012 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recommended therapy
R0:
Stage 1: Gastrectomy alone/PSK
Stage 2-4: F/M/MF and/or PSK
R(+):
Chemotherapy: MF/CF and/or PSK

PSK was administered orally from 14 days after gastrectomy at a dose of 3.0g/day and at least at a dose of over 270g. Fluoropyrimidine prodrug (5-FU 150mg/day or UFT (300mg/day or TS1 40-80mg/day) was administered orally from 14 days after gastrectomy over 1 year. MMC was injected intravenously 0.4 mg/Kg and/or 0.2 mg/Kg intraoperatively, or within 1 month after gastrectomy. CDDP (40-60mg/m2/W 4 times) was administered intravenously after gastrectomy starting from July 1996.
The principles of this study outlined in the Declaration of Helsinki were followed.
The PSGP(UMINID000037472), JCTB(UMINID000037475), and JSCT(UMINID000037483) trials were performed to base on the results of this study. Results, including trials above were reported (Ann. Cancer Res. Therap. Vol. 19,44-53, 2011). As T. Mitomi passed away, an e-mail address of the principal investigator is that of K. Ogoshi.

Management information
Registered date
2019 Year 07 Month 25 Day
Last modified on
2020 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042735

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/07/25 Tokai UMIN登録.xlsx


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