UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059886 |
|---|---|
| Receipt number | R000059776 |
| Scientific Title | Observational study of cancer patients who underwent body fluid testing, including thoracentesis |
| Date of disclosure of the study information | 2025/11/26 |
| Last modified on | 2025/11/26 14:46:30 |
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Basic information
Public title
Observational studies on malignant pleural effusions
Acronym
Observational studies on malignant pleural effusions
Scientific Title
Observational study of cancer patients who underwent body fluid testing, including thoracentesis
Scientific Title:Acronym
Observational study of cancer patients who underwent body fluid testing, including thoracentesis
Region
| Japan |
Condition
Condition
Malignant tumors including lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the characteristics of cancer patients with body cavity effusion through analyses of laboratory findings of effusion samples, clinical courses, and various assessments using previously collected specimens.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positivity rate of cytological examination of aspirated effusion
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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 a pathologically confirmed diagnosis of malignant neoplasm.
Patients with active malignant disease who underwent collection of body cavity effusion (e.g., therapeutic drainage or diagnostic aspiration) due to suspected malignant pleuritis, peritonitis, or pericarditis.
Patients who have been seen in the Department of Respiratory Medicine or the Department of Thoracic Surgery.
Key exclusion criteria
Patients deemed inappropriate for participation in this study by the principal investigator or a co-investigator.
Patients who have requested not to participate in this study.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Terai |
Organization
Keio University
Division name
Department of Respiratory Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
hidekit926@gmail.com
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Ogata |
Organization
Keio University
Division name
Department of Respiratory Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
ogatank606@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
ogatank606@gmail.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | 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
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
| 2023 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a descriptive observational study without interventions or control groups, targeting cancer patients with body cavity effusion who have undergone effusion collection. The aim is to elucidate the characteristics of this patient population by analyzing laboratory findings of effusion samples, clinical courses, and various assessments using previously collected specimens.
Management information
Registered date
| 2025 | Year | 11 | Month | 26 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059776
