UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022030 |
|---|---|
| Receipt number | R000025383 |
| Scientific Title | Genetic screening of oncogenic drivers in squamous cell carcinoma |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2021/11/02 13:36:02 |
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Basic information
Public title
Genetic screening of oncogenic drivers in squamous cell carcinoma
Acronym
Genetic screening of oncogenic drivers in squamous cell carcinoma
Scientific Title
Genetic screening of oncogenic drivers in squamous cell carcinoma
Scientific Title:Acronym
Genetic screening of oncogenic drivers in squamous cell carcinoma
Region
| Japan |
Condition
Condition
Squamous cell carcinoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
FGFR genetic screening in squamous cell carcinoma
Basic objectives2
Others
Basic objectives -Others
Survival benefit of the patients with molecular targeted therapy in squamous cell carcinoma
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the detected frequency of a FGFR alteration in squamous cell carcinoma
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with lung squamous cell carcinoma, esophageal cancer, or head and neck carcinoma
2) To have a formalin-fixed paraffin embedded tissues for genetic analysis. However, patients with insufficient amount of tissue is allowable.
3) Informed consent for the study
4) Patients with existing anticancer treatment is allowable
Key exclusion criteria
1) Patients who are not possible subjects of anticancer drug treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nishio Kazuto |
Organization
Kindai University Faculty of Medicine
Division name
Department of Genome Biology
Zip code
Address
377-2 Ohno-Higashi Osaka-Sayama, Osaka
TEL
072-366-0221
knishio@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakai Kazuko |
Organization
Kindai University Faculty of Medicine
Division name
Department of Genome Biology
Zip code
Address
377-2 Ohno-Higashi Osaka-Sayama, Osaka
TEL
072-366-0221
Homepage URL
kasakai@med.kindai.ac.jp
Sponsor or person
Institute
Department of Genome Biology, Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kindai University Faculty of Medicine
Tokyo Medical University
The Cancer Institute Hospital Of JFCR
Kyushu University Hospital
Kurume University School of Medicine
Name of secondary funder(s)
Astellas Pharma Inc.
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
| 2016 | Year | 05 | Month | 01 | 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
49
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
| 2016 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 04 | Month | 22 | Day |
Last modified on
| 2021 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025383
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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