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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000041971 |
Receipt No. | R000047896 |
Scientific Title | Examination of CD109 expression in head and neck cancer |
Date of disclosure of the study information | 2020/10/01 |
Last modified on | 2020/10/01 |
Basic information | ||
Public title | Examination of CD109 expression in head and neck cancer | |
Acronym | Examination of CD109 expression in head and neck cancer | |
Scientific Title | Examination of CD109 expression in head and neck cancer | |
Scientific Title:Acronym | Examination of CD109 expression in head and neck cancer | |
Region |
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Condition | ||
Condition | Head and neck cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate whether CD109 can be a biomarker in predicting the prognosis of head and neck cancer |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Correlation between the presence or absence of CD109 expression and OS and PFS |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
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Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
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Eligibility | ||||
Age-lower limit |
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Gender | Male and Female | |||
Key inclusion criteria | Among patients treated for head and neck cancer at Kitasato University Hospital between January 1, 2008 and December 31, 2013, biopsy was performed at Kitasato University Hospital Pathology Department and Otolaryngology / Head and Neck Surgery Patients with preserved formalin-fixed paraffin-embedded specimens of tissue and surgically resected tissue | |||
Key exclusion criteria | None | |||
Target sample size | 500 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kitasato University | ||||||
Division name | Otorhinolaryngology / Head and Neck Surgery | ||||||
Zip code | 252-0373 | ||||||
Address | 1-15-1 Kitazato Minami-ku Sagamihara Kanagawa Japan | ||||||
TEL | 042-778-8111 | ||||||
tyamahns@kitasato-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kitasato University | ||||||
Division name | Otorhinolaryngology / Head and Neck Surgery | ||||||
Zip code | 252-0373 | ||||||
Address | Otorhinolaryngology / Head and Neck Surgery | ||||||
TEL | 042-778-8111 | ||||||
Homepage URL | |||||||
dm18020@st.kitasato-u.ac.jp |
Sponsor | |
Institute | Kitasato University |
Institute | |
Department |
Funding Source | |
Organization | Kitasato University |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Kitasato University School of Medicine / Hospital Ethics Committee |
Address | 1-15-1 Kitazato Minami-ku Sagamihara Kanagawa Japan |
Tel | 042-778-81118273 |
rinri@med.kitasato-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 | |
Results | |
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Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Other | |
Other related information | This study is a retrospective observational study. We will perform immunohistochemical staining using tissue specimens of patients stored at our hospital and collect information from medical records. |
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/ctr_e/ctr_view.cgi?recptno=R000047896 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |