UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056183 |
|---|---|
| Receipt number | R000051591 |
| Scientific Title | Single-center prospective study of the relationship between the changes of immunological and nutritional values before and after radiation therapy and prognosis |
| Date of disclosure of the study information | 2024/11/18 |
| Last modified on | 2026/05/10 09:46:38 |
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Basic information
Public title
Single-center prospective study of the relationship between the changes of immunological and nutritional values before and after radiation therapy and prognosis
Acronym
Single-center prospective study of the relationship between the changes of immunological and nutritional values before and after radiation therapy and prognosis
Scientific Title
Single-center prospective study of the relationship between the changes of immunological and nutritional values before and after radiation therapy and prognosis
Scientific Title:Acronym
immunological and nutritional study
Region
| Japan |
Condition
Condition
Lung cancers
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A prospective analysis of how the changes of immunological and nutritional values before and after chest radiation therapy affected the prognosis of patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival, Local control rate, Progression free survival, Local/regional lymphatic recurrence rate, Distant metastatic rate.
Key secondary outcomes
The occurrence rate of radiation-induced lung injury and esophagitis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent radiation therapy for chest disease from Jan 1, 2020 to December 31, 2023
Key exclusion criteria
Patients for whom the principal investigator and the research coordinator are deemed unsuitable for participation in this study
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiko |
| Middle name | |
| Last name | Oguri |
Organization
Shizuoka General Hospital
Division name
Department of radiology
Zip code
420-8527
Address
4-27-1 Kita Ando Aoi-ku, Shizuoka City
TEL
+81-54-247-6111
kurikuriayumi@gmail.com
Public contact
Name of contact person
| 1st name | Zhe |
| Middle name | |
| Last name | Chen |
Organization
University of Yamanashi Hospital
Division name
Department of radiology
Zip code
409-3898
Address
1110 Shimokato, Chuo, Yamanashi
TEL
+81-55-273-1111
Homepage URL
z.chenmd@live.com
Sponsor or person
Institute
Department of radiology, Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of radiology, Shizuoka General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka General Hospital
Address
4-27-1 Kita Ando Aoi-ku, Shizuoka City
Tel
+81-54-247-6111
z.chenmd@live.com
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
| 2024 | Year | 11 | Month | 18 | Day |
Related information
URL releasing protocol
The study protocol has not been publicly released.
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-026-45248-z
Number of participants that the trial has enrolled
92
Results
Eighty-two patients were analyzed. At a median follow-up of 30.2 months, 2-year OS, LCR, and DFFR were 85.4%, 86.5%, and 80.1%. High mGPS was significantly associated with inferior OS and remained an independent prognostic factor in both the overall and SBRT cohorts.
Results date posted
| 2026 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 03 | Month | 19 | Day |
Baseline Characteristics
The median age was comparable between the low and high mGPS groups (78 vs. 79 years, p = 0.432). Patients in the high mGPS group were more frequently male than those in the low mGPS group (84.8% vs. 61.2%, p = 0.027). The distribution of disease stage and the presence or absence of pathological confirmation did not significantly differ between groups. However, SBRT was less frequently administered in the high mGPS group than in the low mGPS group (54.5% vs. 79.6%, p = 0.030).
Participant flow
A total of 92 patients were enrolled between January 2021 and March 2023. After excluding 4 patients who withdrew consent and 6 patients with incomplete data, 82 patients were included in the final analysis.
Adverse events
Adverse events were not predefined as study endpoints and were not collected or analyzed in this analysis.
Outcome measures
The primary endpoint was 2-year overall survival (OS). Secondary endpoints included 2-year local control rate (LCR) and distant failure-free rate (DFFR).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 01 | Day |
Other
Other related information
Observation and inspection items
1. Patient background (age, sex, complications, medical history, smoking history, family history, presence or absence of allergies)
2. Physical findings (lesion site, height, weight, BMI)
3. Nutrition status questionnaire (Patient Generated-Subjective Global Assessment)
4. Peripheral blood test findings (peripheral blood findings, white blood cell image, biochemical test findings)
5. Physiological test findings (respiratory function test findings)
6. Histopathological results (tumor diameter, histological type, disease findings, background lung findings)
7. Radiation therapy related indicators (irradiation dose, number of irradiations, lung dose, cardiac dose, esophageal dose, etc.)
8. Prognosis description (presence or absence of recurrence, presence or absence of adverse events, date of final survival confirmation, live or death, date and time of death)
Management information
Registered date
| 2024 | Year | 11 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051591
