UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005037 |
|---|---|
| Receipt number | R000005990 |
| Scientific Title | Clinical Significance of Circulating Tumor Cells in in-operable Lung Cancer |
| Date of disclosure of the study information | 2011/02/06 |
| Last modified on | 2014/05/21 13:54:27 |
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Basic information
Public title
Clinical Significance of Circulating Tumor Cells in in-operable Lung Cancer
Acronym
Clinical Significance of Circulating Tumor Cells in in-operable Lung Cancer
Scientific Title
Clinical Significance of Circulating Tumor Cells in in-operable Lung Cancer
Scientific Title:Acronym
Clinical Significance of Circulating Tumor Cells in in-operable Lung Cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate relation ships between the change in number of circulating tumor cells in peripheral blood and incidence of recurrent disease or prognosis.
Basic objectives2
Others
Basic objectives -Others
To evaluate relation ships between the change in number of circulating tumor cells in peripheral blood and incidence of recurrent disease or prognosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To elucidate the rlationship between CTC and OS(over all survival).
Key secondary outcomes
To elucidate the rlationship between CTC and DFS (disease free survival), tumor response and recurrence site.
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.Diagnosed as lung cancer by histology/cytology
2.No prior treatment
3.In-operable
4. Measureable disease
5. Written informed consent
Key exclusion criteria
1.Double cancer
2.sevior complication of major organ
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
hy0522@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
Homepage URL
hy0522@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata Lung Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
Niigata Foundation of the Promotion of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
新潟肺癌治療研究会参加施設
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 05 | Month | 01 | Day |
Other
Other related information
To elucidate whether CTC of pre and post standard tratment could be a prognostic factor of lung cancer.
Management information
Registered date
| 2011 | Year | 02 | Month | 06 | Day |
Last modified on
| 2014 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005990
