UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006508 |
|---|---|
| Receipt number | R000007722 |
| Scientific Title | A clinical study of intraoperative diagnosis of sentinel lymph node metastasis in head and neck cancer patients using bimolecular methods |
| Date of disclosure of the study information | 2011/10/12 |
| Last modified on | 2012/04/10 08:12:46 |
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Basic information
Public title
A clinical study of intraoperative diagnosis of sentinel lymph node metastasis in head and neck cancer patients using bimolecular methods
Acronym
Intraoperative diagnosis of lymph node metastasis in head and neck cancer patients using one-step nucleic acid amplification
Scientific Title
A clinical study of intraoperative diagnosis of sentinel lymph node metastasis in head and neck cancer patients using bimolecular methods
Scientific Title:Acronym
Intraoperative diagnosis of lymph node metastasis in head and neck cancer patients using one-step nucleic acid amplification
Region
| Japan |
Condition
Condition
Oral cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a more efficient method for intraoperative detection of lymph node metastasis in head and neck cancer patients using bimolecular methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We evaluate the concordance rate between the OSNA assay and histopathology for lymph node metastases.
Key secondary outcomes
Cutoff values to distinguish macrometastasis, micrometastasis, and nonmetastasis are determined by measuring cytokeratin 19 (CK19) mRNA in histopathologically positive and negative lymph nodes using OSNA.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
We evaluate the lymph node metastasis in head and neck cancer patients using bimolecular methods.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Previously untreated head and neck squamous cell carcinoma patients who surgical resection are indicated as a primary treatment, are the candidates for our study.
Key exclusion criteria
1)Previously treated patients
2)Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhisa Hasegawa |
Organization
Aichi Cancer Center
Division name
Department of Head and Neck Surgery
Zip code
Address
1-1 Kanokoden Chikusaku, Nagoya 464-8681, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhisa Hasegawa |
Organization
Aichi Cancer Center
Division name
Department of Head and Neck Surgery
Zip code
Address
1-1 Kanokoden Chikusaku, Nagoya 464-8681, Japan
TEL
052-762-6111
Homepage URL
hasegawa@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Sciences Research Grant for Clinical Cancer Research (H21-Gannorinshou-Ippan-016)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1)Fukushima Medical University
2)Kyorin University
3)Gunma University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 10 | Month | 12 | 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
Completed
Date of protocol fixation
| 2008 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 09 | Day |
Last modified on
| 2012 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007722
