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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027091
Receipt No. 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 2018/04/22

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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
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, and urothelial cancer treated with immune checkpoint inhibitors (Ipilimumab, Nivolumab, Pembrolizumab) 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) 100 patients undergoing treatment with Nivolumab or Pembrolizumab among patients diagnosed with non-small cell lung cancer.
(2) 50 patients undergoing treatment with Nivolumab among patients diagnosed with kidney cancer.
(3) 20 patients undergoing treatment with Ipilimumab, Nivolumab, 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 among patients diagnosed with head and neck cancer.
(6) 50 patients undergoing treatment with Nivolumab among patients diagnosed with gatric cancer.
(7) 50 patients undergoing treatment with Pembrolizumab among patients diagnosed with urothelial cancer.
Key exclusion criteria (1) Minor
(2) Difficult to obtain consent
Target sample size 310

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuro SASADA
Organization Kanagawa Cancer Center Research Institute
Division name Division of Cancer Immunotherapy
Zip code
Address Yokohama-city Kanagawa prefecture
TEL 045-520-2222
Email tsasada@kcch.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumiko MIDORIKAWA
Organization Kanagawa Cancer Center
Division name Cancer Vaccine Center
Zip code
Address Yokohama-city Kanagawa prefecture
TEL 045-520-2222
Homepage URL
Email midorikawa@gancen.asahi.yokohama.jp

Sponsor
Institute Kanagawa Cancer Center Research Institute
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 04 Month 24 Day
Last follow-up date
2022 Year 12 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
2018 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031051

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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