UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002911 |
|---|---|
| Receipt number | R000003216 |
| Scientific Title | Clinical Significance of Circulating Tumor Cells in Completely Resected Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2010/01/15 |
| Last modified on | 2009/11/30 23:31:11 |
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Basic information
Public title
Clinical Significance of Circulating Tumor Cells in Completely Resected Non-Small Cell Lung Cancer
Acronym
Clinical Significance of Circulating Tumor Cells in Completely Resected Non-Small Cell Lung Cancer
Scientific Title
Clinical Significance of Circulating Tumor Cells in Completely Resected Non-Small Cell Lung Cancer
Scientific Title:Acronym
Clinical Significance of Circulating Tumor Cells in Completely Resected Non-Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
non-samll cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate relation ships between the change in number of circulating tumor cells in peripheral blood or the number of circulating tumor cells in pulmonary vein and incidence of recurrent disease or prognosis.
Basic objectives2
Others
Basic objectives -Others
Prognostic Significance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To elucidate the rlationship between peri/pv CTC and OS(over all survival)/DFS(disease free survival).
Key secondary outcomes
To evaluate the influence of surgical procedure on the number of CTC.
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
blood sampling from peripheral vein/intraoperative blood sampling from drainage pulmonary vein
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
1.Diagnosed as NSCLC by histology/cytology(except low grade malignancy such as Carcinoid, Adenoidcystic carcinoma, Mucoepidermoid Carcinoma
2.cStage I or II
3.at least lobectomy will be performed
4. ECOG PS 0-1
5. Written informed consent
Key exclusion criteria
1.Double cancer:simaltaneous or sequential with more than 5 years disease interval.
2.sevior complication of major organ
3.pregnant or having intention to have child or giving the breast feeding
4.sever alergy against paticular drug
5.mental disorder
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Date Hiroshi |
Organization
Kyoto University Hospital
Division name
Respiratory Surgery
Zip code
Address
54 Kawaharacho Shougoin Sakyo Kyoto
TEL
075-751-4975
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyahara Ryo |
Organization
Kyoto University Hospital
Division name
Respiratory Surgery
Zip code
Address
TEL
Homepage URL
rmiyahar@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Surgery
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Surgery
Kyoto University Hospital
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
| 2010 | Year | 01 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 16 | Day |
Last modified on
| 2009 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003216
