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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043548
Receipt No. 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 2021/03/08

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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
Email 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
Email takegawa@hp.pref.hyogo.jp

Sponsor
Institute Hyogo cancer center
Institute
Department

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
Email 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
2024 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
2021 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048569

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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