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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 | UMIN000031964 |
Receipt No. | R000036499 |
Scientific Title | The prediction of lateral lymph node metastasis using One Step Nucleic Acid Amplification method in the rectal cancer |
Date of disclosure of the study information | 2018/03/29 |
Last modified on | 2021/04/16 |
Basic information | ||
Public title | The prediction of lateral lymph node metastasis using One Step Nucleic Acid Amplification method in the rectal cancer | |
Acronym | The prediction of lateral lymph node metastasis using OSNA method in the rectal cancer | |
Scientific Title | The prediction of lateral lymph node metastasis using One Step Nucleic Acid Amplification method in the rectal cancer | |
Scientific Title:Acronym | The prediction of lateral lymph node metastasis using OSNA method in the rectal cancer | |
Region |
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Condition | ||
Condition | rectal cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To adjust the object of lateral lymph node dissection |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | The negative predictive value of mesorectal OSNA diagnosis for pathological lateral lymph node metastasis |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Locally advanced lower rectal cancer undergoing mesorectal excision and lateral lymoh node dissection | |||
Key exclusion criteria | Neoadjuvant therapy | |||
Target sample size | 24 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Yokohama City University | ||||||
Division name | Department of Sugery | ||||||
Zip code | |||||||
Address | 3-9 Fukuura Kanazawa-ku Yokohama Kanagawa | ||||||
TEL | 045-787-2645 | ||||||
numata@yokohama-cu.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Yokohama City University | ||||||
Division name | Department of Surgery | ||||||
Zip code | |||||||
Address | 3-9 Fukuura Kanazawa-ku Yokohama Kanagawa | ||||||
TEL | 045-787-2645 | ||||||
Homepage URL | |||||||
numata@yokohama-cu.ac.jp |
Sponsor | |
Institute | Yokohama City University, Department of Surgery |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Kanagawa Cancer Center Yokohama Minami Kyousai Hospital Fujisawa Syounandai Hospital |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 | |
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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 | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information | none |
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=R000036499 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |