UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050388 |
|---|---|
| Receipt number | R000057372 |
| Scientific Title | An observational study to retrospectively compare peripheral blood lymphocyte counts during X-ray and carbon ion radiotherapy for pancreatic cancer. |
| Date of disclosure of the study information | 2023/02/26 |
| Last modified on | 2024/09/05 11:45:52 |
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Basic information
Public title
Comparison of Lymphopenia after X-ray Radiotherapy and Carbon-Ion Therapy in Pancreatic Cancer
Acronym
Comparison of Lymphopenia in Pancreatic Cancer
Scientific Title
An observational study to retrospectively compare peripheral blood lymphocyte counts during X-ray and carbon ion radiotherapy for pancreatic cancer.
Scientific Title:Acronym
Pancreatic Cancer Carbon Ion Radioherapy Peripheral Blood Lymphocyte Count
Region
| Japan | Asia(except Japan) |
Condition
Condition
Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze the relationship between peripheral blood lymphocyte counts and treatment efficacy in patients treated with X-ray therapy for pancreatic cancer at Yonsei University and carbon ion beam therapy at QST Hospital, and to clarify the efficacy of carbon ion radiotherapy on immune response compared to X-ray therapy.
Basic objectives2
Others
Basic objectives -Others
This study is a retrospective observational study of previously treated cases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the incidence of lymphopenia after radiotherapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pancreatic cancer who received neoadjuvant or definitive radiotherapy to the pancreatic area between January 2005 and December 2015
Key exclusion criteria
1) Salvage aim (RT for recurrent pancreatic cancer)
2) Prior radiotherapy to the abdomen area
3) Previous history of other types of cancer
4) Distant metastasis
5) Follow-up period of less than 6 months
6) Neuroendocrine tumor
7). If the research subject or his/her representative refuses to allow the use of his/her clinical data for this research
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Yamada |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
2638555
Address
4-9-1 Anagawa, Inageku, Chiba 263-8555, Japan
TEL
043-206-3306
yamda.shigeru@qst.go.jp
Public contact
Name of contact person
| 1st name | Shiegru |
| Middle name | |
| Last name | Yamada |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
2638555
Address
4-9-1 Anagawa, Inageku, Chiba 263-8555, Japan
TEL
043-206-3306
Homepage URL
yamada.shigeru@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yonsei University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology
Address
4-9-1 Anagawa, Inageku, Chiba 263-8555, Japan
Tel
043-206-3306
helsinki@qst.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
4-2019-1000
Org. issuing International ID_1
Yonsei University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | 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
834
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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 09 | 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
Observational study to compare lymphocyte trends in pancreatic cancer cases treated with X-ray therapy at Yonsei University from January 2005 to December 2015 and pancreatic cancer cases treated with carbon ion radiotherapy at QST Hospital from January 2005 to December 2015.
Management information
Registered date
| 2023 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057372
