UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042276 |
|---|---|
| Receipt number | R000048266 |
| Scientific Title | Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in head and neck cancer |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2023/05/02 10:57:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in head and neck cancer
Acronym
Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in head and neck cancer
Scientific Title
Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in head and neck cancer
Scientific Title:Acronym
Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in head and neck cancer
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the expression of small RNAs associated with diagnostic, recurrence, and therapeutic effects in patients diagnosed with head and neck cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Small RNAs associated with diagnosis
2) Investigate the relationship between the following items and the expression status of small RNAs
<Patient background>
Patient age, gender, primary site, stage, treatment method and information on results and course, information on recurrence and metastasis, information on unfollowable or termination due to transfer, etc.
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
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically diagnosed as head and neck cancer
2) Scheduled treatment at our hospital
3) 20 years old and over
4) Expected to survive for 120 days or more
5) The consent has been obtained
Key exclusion criteria
1) Have a history or complication of other cancers
2) Judged as lacking consent due to dementia or mental illness
3)Patients who have decided inappropriate to include in this study by the investigators
Target sample size
475
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Tahara |
Organization
National Cancer Center Hospital East
Division name
Department of Head and Neck Medical Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa city, Chiba, Japan
TEL
04-7133-1111
matahara@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Kodani |
Organization
MiRTeL Co.Ltd.
Division name
Research and Development Division
Zip code
734-0001
Address
1-2-10 Deshio Minami-ku, Hiroshima city, Hiroshima, Japan
TEL
082-546-9797
Homepage URL
kenkyu@mirtel.co.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
MiRTeL Co.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa city, Chiba, Japan
Tel
04-7133-1111
irst@ml.res.ncc.go.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
| 2020 | Year | 10 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate the relationship between the following items and the expression status of small RNAs
<Patient background>
Patient age, gender, primary site, stage, treatment method and information on results and course, information on recurrence and metastasis, information on unfollowable or termination due to transfer, etc.
Management information
Registered date
| 2020 | Year | 10 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048266
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
