UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019129 |
|---|---|
| Receipt number | R000022115 |
| Scientific Title | Analyses of immune status of patients with gastrointestinal cancer |
| Date of disclosure of the study information | 2015/09/27 |
| Last modified on | 2023/10/03 09:46:56 |
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Basic information
Public title
Analyses of immune status of patients with gastrointestinal cancer
Acronym
Immune monitoring in GI cancer
Scientific Title
Analyses of immune status of patients with gastrointestinal cancer
Scientific Title:Acronym
Immune monitoring in GI cancer
Region
| Japan |
Condition
Condition
Gastrointestinal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the profile of immune cells and immune factors in tumor tissue or peripheral blood
Basic objectives2
Others
Basic objectives -Others
To evaluate relationship between immune profile and clinicopatholigical features as well as treatment response and prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
immune profile in gastrointestinal cancers
Key secondary outcomes
Association between immune profile and clinicopatholigical features as well as treatment response and prognosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with histologically confirmed or clinically suspected advanced cancer or malignant tumor of following descriptions; 1.gastric cancer 2.Esophageal cancer 3.colorectal cancer 4. GIST
2) Planned to receive surgery or systemic chemotherapy (one or more enrollment is possible per patient)
3) Plan to acquire sufficient tumor materials or sufficient archival materials to analyze
4) Written informed consent was obtained
Key exclusion criteria
1) Patient is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Nishikawa |
Organization
National Cancer Center Hospital East
Division name
EPOC TR department
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
hnishika@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Shitara |
Organization
National Cancer Center Hospital East
Division name
Gastrointestinal Oncology Division
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
kshitara@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in National Cancer Center Hospital
Address
Tsukiji 5-1-1
Tel
03-3542-2511
NCC_IRBoffice@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
| 2015 | Year | 09 | Month | 27 | 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
| 2015 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study. Patients who met eligibility criteria with written informed consent will be enrolled since Sep. 2015. Immune profile will be evaluated in serum and tumor samples.
Management information
Registered date
| 2015 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022115
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
