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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022030
Receipt No. 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 2019/10/29

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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
Email 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
Email kasakai@med.kindai.ac.jp

Sponsor
Institute Department of Genome Biology, Kindai University Faculty of Medicine
Institute
Department

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
Email

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
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 No longer recruiting
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
2019 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025383

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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