UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043516 |
|---|---|
| Receipt number | R000049590 |
| Scientific Title | The clinical study to investigate between immune and gene-expression profile and clinical significance |
| Date of disclosure of the study information | 2021/03/15 |
| Last modified on | 2022/03/03 15:24:04 |
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Basic information
Public title
The clinical study to investigate between immune and gene-expression profile and clinical significance
Acronym
GENOIMMUNE-CRC
Scientific Title
The clinical study to investigate between immune and gene-expression profile and clinical significance
Scientific Title:Acronym
GENOIMMUNE-CRC
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We clarify the clinical significance of immune status and gene-expression profile by comprehensive analyses. Through the analyses, we investigate the new treatment strategy.
Basic objectives2
Others
Basic objectives -Others
Biomarker study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The clinical significance of immune and gene-expression profile in colorectal cancer
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with colorectal cancer whose tumor specimens and blood samples were collected in both clinical practice and clinical trial
Key exclusion criteria
None
Target sample size
338
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Bando |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi
TEL
052-762-6111
Homepage URL
hbando@aichi-cc.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ono pharmaceutical
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
National Cancer Center Institutional Review Board
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-1111
irst@ml.res.ncc.go.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
| 2021 | Year | 03 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate the change of immune and gene-expression profiles between pre and post chemotherapy, radiotherapy, and immune-checkpoint inhibitor.Additionally, we investigate the correlations between change of immune and gene-expression profiles and efficacies of immune-checkpoint inhibitor.
Management information
Registered date
| 2021 | Year | 03 | Month | 03 | Day |
Last modified on
| 2022 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049590
