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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037478
Receipt No. R000042725
Scientific Title Evaluation of pathophysiology of cancer based on HLA and APRs.
Date of disclosure of the study information 2019/07/29
Last modified on 2019/07/24

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Basic information
Public title Evaluation of pathophysiology of cancer based on HLA and APRs.
Acronym Japan cancer treatment and behavior study group (JCTB study)
Scientific Title Evaluation of pathophysiology of cancer based on HLA and APRs.
Scientific Title:Acronym Japan cancer treatment and behavior study group (JCTB study)
Region
Japan

Condition
Condition Esophageal cancer
Gastric cancer
Colorectal cancer
Liver cancer
Pancreatic cancer
Gallbladder and bili duct cancer
Breast cancer
Lung cancer
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the association among HLA, APRs and host factors such as body weight, BMI, and cancer family history with the cancer risk and prognosis.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association between HLA and the cancer risk.
Key secondary outcomes The association between Host factors and the cancer risk.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Gene
Interventions/Control_1 Examination of HLA and APR
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 Biopsy-proven primary cancer patients who gave informed consent.
Key exclusion criteria not particular
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Kaichi
Middle name
Last name Isono
Organization Chiba University
Division name Department of Surgery
Zip code 263-8522
Address 1-33 Yayoichou, Inageku , Chiba, 263-8522, Japan
TEL 043-251-1111
Email iso2218@clock.ocn.ne.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 Japan cancer treatment and behavior study group (JCTB)
Institute
Department

Funding Source
Organization Daiichi Sankyo Company
Kureha Chemical Industry
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan cancer treatment and behavior study group (JCTB)
Address 1-33 Yayoichou, Inageku , Chiba, 263-8522, Japan
Tel 043-251-1111
Email iso2218@clock.ocn.ne.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
2019 Year 07 Month 29 Day

Related information
URL releasing protocol https://doi.org/10.4993/acrt.14.23 https://doi.org/10.4993/acrt.13.37 https://doi.org/10.4993/acrt19
Publication of results Partially published

Result
URL related to results and publications https://doi.org/10.4993/acrt.14.23 https://doi.org/10.4993/acrt.13.37
Number of participants that the trial has enrolled 967
Results
The frequencies of HLA A33, B44, Cw3, DR6, DR8, DR9 and DQ4 antigens were lower in total; therefore, these antigens may act as defensive factors of carcinogenesis.
Results date posted
2019 Year 07 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Nine hundred sixty seven patients enrolled in this study. Median age (range) was 61 years old (26-91 years old), and male and female, 638 and 329, respectively.
Participant flow
Gastric cancer (n=57), esophageal cancer (n=192), colorectal cancer (n=216), liver cancer (n=125), gall bladder and common bile duct cancer (n=21), pancreatic cancer (n=47), lung cancer (n=186), breast cancer (n=123) were enrolled.
Adverse events
not particular
Outcome measures
HLA and host factors and cancer risk
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
1990 Year 10 Month 01 Day
Date of IRB
1990 Year 10 Month 01 Day
Anticipated trial start date
1990 Year 12 Month 01 Day
Last follow-up date
1998 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information When we started this clinical research in 1990 our research was thought as observational research, but now as interventional type. Then we selected the interventional research form.
JCTB Research Board discussed our research protocol based on the principles outlined in the Declaration of Helsinki.

Management information
Registered date
2019 Year 07 Month 24 Day
Last modified on
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042725

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/07/25 JCTB UMIN全癌登録.xlsx


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