UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047648
Receipt No. 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

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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
Email 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
Email nsawabata@hotmail.com

Sponsor
Institute Nara Medical University
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054332

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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