UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037478 |
|---|---|
| Receipt number | 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 | 2023/04/13 11:29:47 |
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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
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
ogoshi@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Japan cancer treatment and behavior study group (JCTB)
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/acrt/31/1/31_13/_article/-char/ja
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
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042725
