UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000035362 |
| Receipt No. | R000040290 |
| Scientific Title | Prospective exploratory diagnstic trial for evaluation of breast cancer detecting method by analyzing volatile organic compounds (VOCs) in exhaled air |
| Date of disclosure of the study information | 2018/12/25 |
| Last modified on | 2020/06/30 (Ver. 5) |
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| Basic information | ||
| Public title | Prospective exploratory diagnstic trial for evaluation of breast cancer detecting method by analyzing volatile organic compounds (VOCs) in exhaled air | |
| Acronym | VOCs trial for detecting breast cancer | |
| Scientific Title | Prospective exploratory diagnstic trial for evaluation of breast cancer detecting method by analyzing volatile organic compounds (VOCs) in exhaled air | |
| Scientific Title:Acronym | VOCs trial for detecting breast cancer | |
| Region |
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| Condition | ||
| Condition | breast cancer
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| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | identify VOC biomarker in exhaled air for detecting breast cancer |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | sensitivity and specificity of breast cancer detection using VOC |
| Key secondary outcomes | positive predictive value and negative predictive value |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Single arm |
| Randomization | Non-randomized |
| Randomization unit | |
| Blinding | Open -no one is blinded |
| Control | Historical |
| 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 | collecting exhaled air in the sampler | |
| 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 | Female | |||
| Key inclusion criteria | 1)woman with breast cancer before treatment or woman who wants to have breast screening
2)olader than 35 yo 3)obtained written informed consent |
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| Key exclusion criteria | 1) past history of breast cancer
2) past history of other malignancies 3) who can not be undergo breast biopsy 4) pregnant 5) diabetes mellitus 6) who are taking antihypercholestrolemia |
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| Target sample size | 670 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Showa University hospital | ||||||
| Division name | breast surgery | ||||||
| Zip code | 142-8666 | ||||||
| Address | Hatanodai 1-5-8 Shinagawa-ku, Tokyo | ||||||
| TEL | 03-3784-8000 | ||||||
| seigonak@med.showa-u.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Showa University hospital | ||||||
| Division name | breast surgery | ||||||
| Zip code | 142-8666 | ||||||
| Address | Hatanodai 1-5-8 Shinagawa-ku, Tokyo | ||||||
| TEL | 03-3784-8000 | ||||||
| Homepage URL | |||||||
| sakashi@med.showa-u.ac.jp | |||||||
| Sponsor | |
| Institute | Showa University hospital
breast surgery |
| Institute | |
| Department | |
| Funding Source | |
| Organization | ecsola medical |
| Organization | |
| Division | |
| Category of Funding Organization | Profit organization |
| Nationality of Funding Organization | Japan |
| Other related organizations | |
| Co-sponsor | none |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Institutional review board |
| Address | Hatanodai 1-5-8, Shinagawa-ku, Tokyo |
| Tel | 03-3784-8000 |
| m-rinri@ofc.showa-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 | 昭和大学病院（東京都） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | none |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | none | ||||||
| Number of participants that the trial has enrolled | 675 | ||||||
| Results | not detected |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | patients who visited Showa University Hospital from May 2017 to September 2018 |
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| Participant flow | exhale air into a special vessel |
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| Adverse events | none |
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| Outcome measures | biomarker for distinguishing women with breast cancer or benign disease |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| 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 of closure to data entry |
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| Date trial data considered complete |
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| Date analysis concluded |
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| 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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040290 |
