UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059332 |
|---|---|
| Receipt number | R000067868 |
| Scientific Title | Prospective observational study of ADLs in elderly patients received lung cancer radiotherapy |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/08 12:17:32 |
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Basic information
Public title
Prospective observational study of ADLs in elderly patients received lung cancer radiotherapy
Acronym
PROBITY
Scientific Title
Prospective observational study of ADLs in elderly patients received lung cancer radiotherapy
Scientific Title:Acronym
PROBITY
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate the proportion of patients aged 75 years or older with non-small cell lung cancer who undergo definitive radiotherapy and experience a decline in activities of daily living (ADL) after treatment
Basic objectives2
Others
Basic objectives -Others
To identify patients who experience a marked decline in ADL
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of patients without a decline in instrumental activities of daily living (IADL) at 6 months after radiotherapy
Key secondary outcomes
TMIG-IADL(changs), EQ-5D-5L(changes), overall survival, recurrence-free survival, cumulative incidence of recurrence, incidence of adverse events
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 75 years or older at the time of obtaining informed consent
2) Scheduled to undergo definitive radiotherapy for non-small cell lung cancer
3) No concurrent or sequential chemotherapy planned
4) No prior radiotherapy involving the hilum or mediastinum, including for other cancer types
5) Able to communicate in Japanese and has provided written informed consent to participate in the study
Key exclusion criteria
1) Presence of active double (synchronous) cancer
2) Any other condition judged by the principal investigator to be inappropriate for study participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Nakamura |
Organization
National Cancer Center Hospital East
Division name
Radiation Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
masanaka@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Nakamura |
Organization
National Cancer Center Hospital East
Division name
Radiaiton Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
masanaka@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
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
National Cancer Center Hospital Institutional Review Board
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
Tel
04-7133-1111
irst@ml.res.ncc.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
国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 08 | 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
| 2025 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2030 | Year | 12 | Month | 31 | Day |
Other
Other related information
To prospectively investigate the proportion of patients aged 75 years or older with non-small cell lung cancer who undergo definitive radiotherapy and experience a decline in ADL after treatment
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067868
