UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001896 |
|---|---|
| Receipt number | R000002292 |
| Scientific Title | The clinical significance of circulating tumor cell in metastatic Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2009/04/18 |
| Last modified on | 2013/03/05 13:09:23 |
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Basic information
Public title
The clinical significance of circulating tumor cell in metastatic Non-Small Cell Lung Cancer
Acronym
Circulating Tumor Cell in Non-Small Cell Lung Cancer
Scientific Title
The clinical significance of circulating tumor cell in metastatic Non-Small Cell Lung Cancer
Scientific Title:Acronym
Circulating Tumor Cell in Non-Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
metastatic non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the change of CTC between before and after chemotherapy and radiographic response.
To compare the change of CTC between before and after chemotherapy and progression-free survival or overall survival.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify the relation between CTC and tumor response.
Key secondary outcomes
To clarify the relation between CTC and progression-free survival or overall survival.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) histologically or cytologically confirmed non-small cell lung cancer
2) metastatic disease
3) chemotherapy is scheduled
4) any prior treatment is permitted
5) more than 2 weeks since last administration of chemotherapy
6) measurable disease
7) age: over 20
8) life expectancy: more than 3 months
9) written informed consent
Key exclusion criteria
1) chemotherapy including amurubicin
2) Uncontrolled pleural effusion
3) symptomatic brain metastases
4) active concomitant malignancy
5) serious concurrent illness, such as hypertension, angina pectoris, myocardial infarction, or severe infection
6) pregnant/lactating women
7) history of severe drug allergy
8) psychiatric disease
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Young Hak Kim |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Medicine
Zip code
Address
54 Shogoin-Kawaharacho, Sakyo-Ku, Kyoto 606-8507, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Young Hak Kim |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Medicine
Zip code
Address
TEL
075-751-3830
Homepage URL
Sponsor or person
Institute
Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ortho-Clinical Diagnostics K.K.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2009 | Year | 04 | Month | 18 | 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
Completed
Date of protocol fixation
| 2009 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observation study
Management information
Registered date
| 2009 | Year | 04 | Month | 18 | Day |
Last modified on
| 2013 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002292
