UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060174 |
|---|---|
| Receipt number | R000068821 |
| Scientific Title | Spatial and single-cell analysis of immune responses after X-ray and carbon-ion radiotherapy in cervical cancer |
| Date of disclosure of the study information | 2025/12/23 |
| Last modified on | 2025/12/23 11:18:12 |
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Basic information
Public title
A study to examine immune changes after radiation treatment in patients with cervical cancer
Acronym
C-IMMU-RAD
Scientific Title
Spatial and single-cell analysis of immune responses after X-ray and carbon-ion radiotherapy in cervical cancer
Scientific Title:Acronym
CERV-SPACE-IMMU
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to clarify the differences in immune responses induced after X-ray and carbon-ion radiotherapy in patients with cervical cancer using tumor tissues and peripheral blood samples. Spatial and functional immune changes will be integratively analyzed in relation to two-year local control and overall survival.
Basic objectives2
Others
Basic objectives -Others
Exploratory biological immune response analysis and biomarker discovery.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Two-year local control rate, Two-year overall survival, and Changes in the immune microenvironment (immune cell composition, spatial distribution, gene expression, and TCR diversity)
Key secondary outcomes
Treatment-related adverse events, Correlation with clinical background and treatment course, and Exploratory evaluation of biomarker candidates
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Tumor biopsy and peripheral blood sampling will be performed for research purposes before the initiation of radiotherapy as part of routine clinical diagnosis and during the radiation treatment period as an additional procedure outside routine diagnosis. Collected tumor tissues and blood samples will be used for immune response analyses, including spatial analysis, single-cell analysis, and TCR repertoire analysis.
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
Female
Key inclusion criteria
Patients with cervical cancer scheduled to receive X-ray or carbon-ion radiotherapy
Patients for whom tumor biopsy can be obtained before the initiation of radiotherapy
Patients for whom additional tumor biopsy and peripheral blood sampling during the radiation treatment period for research purposes are feasible
Female patients aged 20 years or older
Patients who have provided written informed consent to participate in this study
Key exclusion criteria
Patients with severe immunosuppressive conditions
Patients who are pregnant or possibly pregnant
Patients judged by the treating physician to be inappropriate for participation in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsuguhide |
| Middle name | |
| Last name | Takeshima |
Organization
National Institutes for Quantum Science and Technology
Division name
Department of Charged Particle Therapy Research, QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba, JAPAN
TEL
043-206-3237
takeshima.tsuguhide@qst.go.jp
Public contact
Name of contact person
| 1st name | Tsuguhide |
| Middle name | |
| Last name | TaTakeshima |
Organization
National Institutes for Quantum Science and Technology
Division name
Department of Charged Particle Therapy Research, QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba, JAPAN
TEL
043-206-3237
Homepage URL
takeshima.tsuguhide@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Tsuguhide Takeshima
Funding Source
Organization
National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba, JAPAN
Tel
043-206-4706
helsinki@qst.go.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
| 2025 | Year | 12 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068821
