UMIN-CTR Clinical Trial

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 in lung cancer patients
Acronym	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	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	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
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	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Frequency of detection of circulating tumor cells in the blood by S-MPF method
Key secondary outcomes	Relationship between blood circulating tumor cells and pathological factors

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	Other
Interventions/Control_1	15 ml of peripheral blood collection
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 more than 2.1cm or CEA more than 7.5ng over ml or SUV max more than 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 more than 3,000 over mm3, less than 12,000 over mm3 Hb more than 9.0g over dl Platelet count more than 10000 over mm3 AST less than 100IU over L, ALT less than100IU over L Total bilirubin less than 1.5mg over dL Serum creatinine less than 1.5mg over 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 hesychastic 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 infections requiring systemic treatment, including HIV, HBV, and HCV infections. 3. Without the use of an antipyretic, there is a fever of 38 centi degree or more at axillary temperature within 24 hours before registration. 4. The company is subjected to continuous systemic administration (internal or intravenous) of steroids or other immunosuppressants. A case in which the attending physician judged it to be 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	General thoracic and Cardiovascular Surgery
Zip code	634-8522
Address	840 Shijo-cho Kashihara city, Nara, Japan
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	General Thoracic and Cardiovascular Surgery
Zip code	634-8522
Address	840 Shijo-cho Kashihara city, Nara, Japan
TEL	+819019654730
Homepage URL
Email	nsawabata@hotmail.com

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 Kashihara City, Nara, Japan
Tel	+81744223051
Email	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	2021 Year 11 Month 27 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	Terminated
Date of protocol fixation	2021 Year 07 Month 17 Day
Date of IRB	2021 Year 09 Month 07 Day
Anticipated trial start date	2021 Year 11 Month 17 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 27 Day
Last modified on	2022 Year 05 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052732