UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049619 |
|---|---|
| Receipt number | R000056447 |
| Scientific Title | A multicenter prospective observational study evaluating the impact of diet for the efficacy of immune checkpoint inhibitors in non-small cell lung cancer patients |
| Date of disclosure of the study information | 2022/11/26 |
| Last modified on | 2024/12/05 11:53:43 |
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Basic information
Public title
A multicenter prospective observational study evaluating the impact of diet for the efficacy of immune checkpoint inhibitors in non-small cell lung cancer patients
Acronym
DIET-ICI study
Scientific Title
A multicenter prospective observational study evaluating the impact of diet for the efficacy of immune checkpoint inhibitors in non-small cell lung cancer patients
Scientific Title:Acronym
DIET-ICI study
Region
| Japan |
Condition
Condition
Non-small cell lung cacner
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of diet on the efficacy of immune checkpoint inhibitorsin patients with non-small cell lung cancer
Basic objectives2
Others
Basic objectives -Others
To clarify the correlation between various blood amino acid and fatty acid levels and the efficacy of immune checkpoint inhibitors in the non-small cell lung cancer patient
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
1) Objective response rate
2) Overall survival
3) Immune-related adverse events
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with histologically or cytologically diagnosed non-small cell lung cancer
2. Patients who receive treatment including immune checkpoint inhibitors (monotherapy or combination therapy) as initial therapy (However, patients with driver gene mutations who have previously been treated with molecular targeted drugs are also acceptable)
3. Patients with her PS 0-2 at enrollment
4. Patients with self-determination ability over 20 years old
5. Patients with written consent
Key exclusion criteria
1. Patients under the age of 20
2. Patients who cannot consent to participate in this study
3. Patients who have insufficient decision-making ability and cannot obtain written informed consent from the patient
4. Patients who are judged to be inappropriate as research subjects by the principal investigator or co-investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Sakagami |
Organization
Kumamoto University Medical Sciences
Division name
Department of Respiratory Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuoh-Ku, Kumamoto City, Japan
TEL
096-373-5012
stakuro@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Saruwatari |
Organization
Kumamoto University Medical Sciences
Division name
Department of Respiratory Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuoh-Ku, Kumamoto City, Japan
TEL
096-373-5012
Homepage URL
ksaruwat@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine Kumamoto University Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Life Sciences, Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
Tel
096-373-5657
ski-shien@jimu.kumamoto-u.ac.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
熊本中央病院（熊本県）,熊本市民病院（熊本県）、くまもと県北病院（熊本県）、熊本労災病院（熊本県）、人吉医療センター（熊本県）、宮崎県立延岡病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The information of diet in non-small cell lung cancer patients receiving immune checkpoint inhibitors is collected using a food intake frequency questionnaire. We investigate the clinical course after the administration immune checkpoint inhibitors in NSCLC patients who was entried this study.
Management information
Registered date
| 2022 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056447
