UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043548 |
|---|---|
| Receipt number | R000048569 |
| Scientific Title | Early nutritional support in metastatic gastrointestinal cancer patients planned to be treated with immuno-checkpoint inhibitors: A Prospective Cohort Study. |
| Date of disclosure of the study information | 2021/03/10 |
| Last modified on | 2024/03/11 13:02:35 |
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Basic information
Public title
Early nutritional support in metastatic gastrointestinal cancer patients planned to be treated with immuno-checkpoint inhibitors: A Prospective Cohort Study.
Acronym
ENTRANCE study
Scientific Title
Early nutritional support in metastatic gastrointestinal cancer patients planned to be treated with immuno-checkpoint inhibitors: A Prospective Cohort Study.
Scientific Title:Acronym
ENTRANCE study
Region
| Japan |
Condition
Condition
metastatic gastrointestinal cancer
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We assess the changes of nutritional status, efficacy of treatment, adverse event, and immune status of the patients treated with immuno-checkpoint inhibitors in early nutritional support
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between patient nutritional status and immune status of the patients
Key secondary outcomes
Nutritional status of the patients, efficacy and safety of immuno-checkpoint inhibitors
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 20 years or older;
2) Patients scheduled for induction of immune checkpoint inhibitor treatment(nivolumab or pembrolizumab)
3) Gastrointestinal function is maintained
Key exclusion criteria
1) Patients who have enteral feeding difficulties
2) Severe major organ dysfunction
3) Active multiple primary cancers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tsuda |
Organization
Hyogo Cancer Center
Division name
Department of Gastroenterology
Zip code
673-8558
Address
13-70 Kitaojityou, Akashishi, Hyogo 673-8558, Japan.
TEL
078-929-1151
b4hkgsntgm7@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Takegawa |
Organization
Hyogo cancer
Division name
Department of Gastroenterology
Zip code
673-8558
Address
13-70 Kitaojityou, Akashishi, Hyogo 673-8558, Japan.
TEL
078-929-1151
Homepage URL
takegawa@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo cancer center
Institute
Department
Personal name
Funding Source
Organization
Hyogo cancer center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo cancer center
Address
13-70 Kitaojityou, Akashishi, Hyogo 673-8558, Japan.
Tel
078-929-1151
rinsyoshikenkanri6@hyogo-cc.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 | 10 | 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 | 11 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We prospectively observe the relationship between the effects of nutritional therapy and treatment with immune checkpoint inhibitors, patient's nutritional status, and patient's immune status
Management information
Registered date
| 2021 | Year | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048569
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
