UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058385 |
|---|---|
| Receipt number | R000066751 |
| Scientific Title | Verification of the usefulness of a filtration membrane (Soft Micro Pore Filter (S-MPF) for separating novel rare cells in peripheral blood circulation tumor cell extraction |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/07 12:04:56 |
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Basic information
Public title
Verification of the usefulness of a filtration membrane (Soft Micro Pore Filter (S-MPF) for separating novel rare cells in peripheral blood circulation tumor cell extraction
Acronym
KMPF
Scientific Title
Verification of the usefulness of a filtration membrane (Soft Micro Pore Filter (S-MPF) for separating novel rare cells in peripheral blood circulation tumor cell extraction
Scientific Title:Acronym
KMPF
Region
| Japan |
Condition
Condition
The usefulness of a filtration membrane (Soft Micro Pore Filter (S-MPF) for isolating novel rare cells in peripheral blood circulation tumor cell extraction is examined.
Classification by specialty
| Pneumology | Chest surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The usefulness of a filtration membrane (Soft Micro Pore Filter (S-MPF) for isolating novel rare cells in peripheral blood circulation tumor cell extraction is examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint: Frequency of detection of circulating carcinoma cells in the blood by the S-MPF method
Key secondary outcomes
Secondary endpoint: Association between circulating cancer cells and pathology
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The patient has been diagnosed with a malignant tumor with a strong probability of clinical diagnosis.
2) The age of registration must be at least 20 years old and not more than 100 years old.
3) ECOG performance status is 0 or 1.
4) The test result must be completed within 30 days prior to the date of registration, and all of the following must be satisfied.
WBC>3,000/mm3, <12,000/mm3
Hb>9.0g/dl
Platelet count> 10x104 /mm3
AST<100IU/L, ALT<100IU/L
Total bilirubin< 1.5mg/dL
Serum creatinine< 2.0mg/dL
5) Cases in which the patient's consent to participate in this study has been obtained in writing
Key exclusion criteria
1) Have an infectious disease that requires systemic treatment, including HIV, HBV, or HCV infection.
2) Have a fever of 38 centi-degrees or higher in axillary temperature within 24 hours prior to enrollment without the use of antipyretics.
3) Cases judged by the attending physician to be inappropriate for conducting this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Sawabata |
Organization
Kawanishi City Medical Cente
Division name
Generak Thoracic Surgery
Zip code
666-0017
Address
Hiuchi 1-4-1 Kawanishi City
TEL
0570-01-8199
nsawabata@hotmail.com
Public contact
Name of contact person
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Sawabata |
Organization
Kawanishi City Medical Cent
Division name
General Thoracic Surgery
Zip code
666-0017
Address
Hiuchi 1-4-1 Kawanishi City
TEL
0570-01-8199
Homepage URL
nsawabata@hotmail.com
Sponsor or person
Institute
kawanishi City Medical 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
Kawanishi City Medical Cen
Address
Hiuchi 1-4-1 Kawanishi City
Tel
0570-01-8199
nsawabata@hotmail.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
| 2025 | Year | 07 | Month | 07 | 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
Suspended
Date of protocol fixation
| 2024 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2035 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066751
