UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047648 |
|---|---|
| Receipt number | R000054332 |
| Scientific Title | Verification of the usefulness of soft Micro Pore Filter: S-MPF, a filtration membrane that separates novel rare cells, in the extraction of peripheral blood circulation tumor cells in lung cancer patients |
| Date of disclosure of the study information | 2022/05/04 |
| Last modified on | 2022/11/03 10:34:17 |
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Basic information
Public title
Verification of the usefulness of soft Micro Pore Filter: S-MPF, a filtration membrane that separates novel rare cells, in the extraction of peripheral blood circulation tumor cells (CTC) in lung cancer patients
Acronym
CTC Filter Test
Scientific Title
Verification of the usefulness of soft Micro Pore Filter: S-MPF, a filtration membrane that separates novel rare cells, in the extraction of peripheral blood circulation tumor cells in lung cancer patients
Scientific Title:Acronym
CTC Filter Test
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness of a filtration membrane (Soft Micro Pore Filter: S-MPF) (patented application P531131) that separates new rare cells in the extraction of peripheral blood circulation tumor cells.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CTC detection rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
CTC extraction by S-MPF: 15ml whole blood
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) It has been diagnosed as non-small cell lung cancer with strong probability in the clinical diagnosis.
2) CT-solid tumor and tumor diameter >2.1cm or CEA>7.5 ng/ml or SUVmax>2.9
3) The age of registration is 20 years old or older and 85 years old or younger.
4) Ecog performance status 0 or 1.
5) No history of chemotherapy or radiation therapy for the chest, including treatment for other cancer species. However, the history of hormonal therapy is acceptable.
6) Complete all of the following with the test results within 30 days before the registration date. 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<1.5mg/dL
7) A case in which the patient's consent is written about the participation of this study
Key exclusion criteria
1) Active malignant tumors (simultaneous malignant tumors and hesichotic malignancies with a disease-free period of less than 5 years). However, lesions equivalent to Carcinoma in situ (intraepithelial cancer) and intramucosal cancer, which are judged to be cured by topical treatment, are not included in active malignant tumors).
2) Patients with infectious diseases requiring systemic treatment, including HIV, HBV, and HCV infections.
3) Without using an antipyretic, there is a fever of 38 centi digree or more at axillary temperature within 24 hours before registration.
4) Continuous systemic administration (internal or intravenous) of steroids or other immunosuppressants.
5) Cases in which the attending physician deems it inappropriate to carry out this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Sawabata |
Organization
Nara Medical University
Division name
Thoracic and Cardiovascular Surgery
Zip code
634-8522
Address
840 Shijo-cho Kashihara, Nara
TEL
+819019654730
nsawabata@hotmail.com
Public contact
Name of contact person
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Sawabata |
Organization
Nara Medical University
Division name
Thoracic and Cardiovascular Surgery
Zip code
634-8522
Address
840 Shijo-cho Kashihara, Nara
TEL
+819019654730
Homepage URL
nsawabata@hotmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840 shijo-cho Nara, Japan
Tel
+81744223051
nsawabata@naramed-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 04 | 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
23
Results
In order to prove the tolerability of S-MPF in clinical practice, a prospective CTC detection rate study was conducted, and the detection rate was almost the same as that of the conventional method (ScreenCell) of 63.4% (33/52) of 63.4% (33/52).
Results date posted
| 2022 | Year | 05 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 04 | Day |
Last modified on
| 2022 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054332
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/05/05 | S-MPF 臨床研究（R1 SAWABATA).docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/05/05 | 登録票.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/05/05 | S-MPF 登録票 R.xlsx |
