UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032363 |
|---|---|
| Receipt number | R000036910 |
| Scientific Title | Radiation induced Activation of Anti-tumor Immunity for Head and Neck Cancer |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2022/02/02 13:30:04 |
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Basic information
Public title
Radiation induced Activation of Anti-tumor Immunity for Head and Neck Cancer
Acronym
Radiation induced Immunity for H&N Cancer
Scientific Title
Radiation induced Activation of Anti-tumor Immunity for Head and Neck Cancer
Scientific Title:Acronym
Radiation induced Immunity for H&N Cancer
Region
| Japan |
Condition
Condition
Head and Neck Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the activation mechanism of anti-tumor immunity induced by radiation therapy for head and neck cancer
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To estimate immune-related factors by measurement substances in blood and histopathological examination for cancer tissues
2. To estimate treatment response and prognosis
3. To summarize treatment outcomes stratified by immune-related factors and clinical characteristics
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients giving written informed consent to participate this study
2.Male or female patients aged 20 years or older at the time of diagnosis of head and neck cancers, who are planned for taking radiation therapy or chemo-radiation therapy.
Key exclusion criteria
1.Patients who are regarded as inappropriate to participate in the study by the primary investigators
2.Patients with serious liver dysfunction or renal dysfunction
3.Pregnant or lactating females
4.Patients with clinically significant psychiatric disease that would interfere with participation in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Toshiyasu |
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JRCR)
Division name
Radiation Oncology Department
Zip code
135-8550
Address
Tokyo Koto-ku Ariake 3-8-31
TEL
03-3520-0111
takashi.toshiyasu@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Toshiyasu |
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JRCR)
Division name
Radiation Oncology Department
Zip code
135-0111
Address
Tokyo Koto-ku Ariake 3-8-31
TEL
03-3520-0111
Homepage URL
takashi.toshiyasu@jfcr.or.jp
Sponsor or person
Institute
The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JRCR)
Institute
Department
Personal name
Funding Source
Organization
Toray Industries, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JRCR)
Address
Tokyo Koto-ku Ariake 3-8-31
Tel
03-3520-0111
takashi.toshiyasu@jfcr.or.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
| 2018 | Year | 05 | Month | 01 | 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
| 2018 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On-going
Management information
Registered date
| 2018 | Year | 04 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036910
