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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 | 2022/05/14 |
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
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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
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Scientific Title:Acronym | CTC Filter Test | |
Region |
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Condition | ||
Condition | Lung cancer | |
Classification by specialty |
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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.
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 25 |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |