UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018086 |
|---|---|
| Receipt number | R000020935 |
| Scientific Title | Circulating free DNA in various diseases and pathologic conditions |
| Date of disclosure of the study information | 2015/06/29 |
| Last modified on | 2019/05/31 10:36:31 |
* 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
Circulating free DNA in various diseases and pathologic conditions
Acronym
Disease and cfDNA
Scientific Title
Circulating free DNA in various diseases and pathologic conditions
Scientific Title:Acronym
Disease and cfDNA
Region
| Japan |
Condition
Condition
Thoracic diseases including lung cancer, pneumonia, interstitila pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) Evaluation of sensitivity and specificity of cfDNA in diagnosis of thoracic diseases
2) Efficacy of cfDNA in diagnosis and monitoring thoracic diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sensitivity and specificity of cfDNA in diagnosis of thoracic diseases
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Examination mainly blood collection
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) Written informed consent
2) Diagnosis or suspect of the disease of interest
Key exclusion criteria
Nothing
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | Imamura |
Organization
Osaka medical center for cancer and cardiovascular diseases
Division name
Department of Thoracic Oncology
Zip code
5418567
Address
1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
TEL
+81-6-6972-1181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Fumio |
| Middle name | |
| Last name | Fumio Imamura |
Organization
Osaka medical center for cancer and cardiovascular diseases
Division name
Department of Thoracic Oncology
Zip code
5418567
Address
1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
TEL
+81-6-6972-1181
Homepage URL
imamura-fu@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka medical center for cancer and cardiovascular diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka medical center for cancer and cardiovascular diseases
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
Osaka Medical Center for Cancer and Cardiovascular Diseases
Address
1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
Tel
669721181
imamura-fu@mc.pref.osaka.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
| 2015 | Year | 06 | Month | 29 | 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
10
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
Terminated
Date of protocol fixation
| 2015 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2019 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020935
