UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021711 |
|---|---|
| Receipt number | R000025047 |
| Scientific Title | Exploratory study on somatic mutation detection using plasma DNA from patients with lung cancer |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2018/04/03 18:45:54 |
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Basic information
Public title
Exploratory study on somatic mutation detection using plasma DNA from patients with lung cancer
Acronym
Mutation detection using plasma DNA
Scientific Title
Exploratory study on somatic mutation detection using plasma DNA from patients with lung cancer
Scientific Title:Acronym
Mutation detection using plasma DNA
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Investigation on usefulness of detection of somatic mutations in cancer-related genes using peripheral blood
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
One blood draw (15 mL)
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
Lung cancer patients who are pathologically or cytologically confirmed
Key exclusion criteria
Not applicable
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Koh |
Organization
Wakayama Medical University
Division name
Third Department of Internal Medicine
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-441-0619
ykoh@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Koh |
Organization
Wakayama Medical University
Division name
Third Department of Internal Medicine
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-441-0619
Homepage URL
ykoh@wakayama-med.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Third Department of Internal Medicine, Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2016 | Year | 03 | Month | 31 | 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
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025047
