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

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 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

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

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


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