UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027091 |
|---|---|
| Receipt number | R000031051 |
| Scientific Title | Identification of biomarker and clarification of resistance mechanism in immune checkpoint inhibitor therapy |
| Date of disclosure of the study information | 2017/04/24 |
| Last modified on | 2023/04/26 09:33:53 |
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Basic information
Public title
Identification of biomarker and clarification of resistance mechanism in immune checkpoint inhibitor therapy
Acronym
IBIC
Scientific Title
Identification of biomarker and clarification of resistance mechanism in immune checkpoint inhibitor therapy
Scientific Title:Acronym
IBIC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Kidney cancer
Malignant melanoma
Classical Hodgkin's lymphoma
Head and neck cancer
Gastric cancer
Urothelial cancer
Microsatellite instability-high (MSI-H) solid tumor
Classification by specialty
| Gastroenterology | Pneumology | Hematology and clinical oncology |
| Gastrointestinal surgery | Dermatology | Oto-rhino-laryngology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Blood is collected from patients with non-small cell lung cancer, kidney cancer, malignant melanoma, classical Hodgkin's lymphoma, head and neck cancer, gastric cancer, urothelial cancer, and microsatellite instability-high (MSI-H) solid tumor treated with immune checkpoint inhibitors (Ipilimumab, Nivolumab, Pembrolizumab, Atezolizumab, Durvalumab, Avelumab) and immunological analysis is performed. Also, stool is collected at the same timing as blood sampling, and the constitution of intestinal micro flora is examined. Furthermore, gene analysis (gene expression and gene mutation analysis) in tumor tissue is performed. Based on results of these analysis, we identify biomarkers useful for patient selection and prognosis prediction, and clarify the mechanism of acquiring resistance to therapeutic drugs.
Basic objectives2
Others
Basic objectives -Others
Clinical application to selection of patients to be applied for immunecheckpoint inhibitors or monitoring after treatment
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical application to selection of patients to be applied for immunecheckpoint inhibitors or monitoring after treatment
Key secondary outcomes
Identification of new biomarkers
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) 200 patients undergoing treatment with Nivolumab, Pembrolizumab, Atezolizumab, Durvalumab, or Ipilimumab among patients diagnosed with non-small cell lung cancer.
(2) 100 patients undergoing treatment with Nivolumab with or without Ipilimumab or Pembrolizumab among patients diagnosed with kidney cancer.
(3) 20 patients undergoing treatment with Ipilimumab, Nivolumab, or Pembrolizumab among patients diagnosed with malignant melanoma.
(4) 10 patients undergoing treatment with Nivolumab among patients diagnosed with classical Hodgkin's lymphoma.
(5) 30 patients undergoing treatment with Nivolumab or Pembrolizumab among patients diagnosed with head and neck cancer.
(6) 50 patients undergoing treatment with Nivolumab among patients diagnosed with gastric cancer.
(7) 100 patients undergoing treatment with Pembrolizumab among patients diagnosed with urothelial cancer.
(8) 50 patients undergoing treatment with Pembrolizumab or Nivolumab among patients diagnosed with MSI-High solid tumor.
Key exclusion criteria
(1) Minor
(2) Difficult to obtain consent
Target sample size
560
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | SASADA |
Organization
Kanagawa Cancer Center Research Institute
Division name
Division of Cancer Immunotherapy
Zip code
2418515
Address
Yokohama-city Kanagawa prefecture
TEL
045-520-2222
tsasada@kcch.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Tomura |
Organization
Kanagawa Cancer Center
Division name
Cancer Vaccine and Immunotherapy Center
Zip code
2418515
Address
Yokohama-city Kanagawa prefecture
TEL
045-520-2222
Homepage URL
yuri-tomura@gancen.asahi.yokohama.jp
Sponsor or person
Institute
Kanagawa Cancer Center Research Institute
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Kanagawa Cancer Center IRB
Address
Yokohama-city Kanagawa prefecture
Tel
045-520-2222
chiken-jimu4@kcch.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
神奈川県立がんセンター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 24 | 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
| 2017 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 24 | 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
None
Management information
Registered date
| 2017 | Year | 04 | Month | 21 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031051
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