UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022594 |
|---|---|
| Receipt number | R000026041 |
| Scientific Title | The study of systemic influence by chemotherapy in elderly patients with lung cancer |
| Date of disclosure of the study information | 2016/06/05 |
| Last modified on | 2016/06/03 13:29:42 |
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Basic information
Public title
The study of systemic influence by chemotherapy in elderly patients with lung cancer
Acronym
The study of systemic influence by chemotherapy in elderly patients with lung cancer
Scientific Title
The study of systemic influence by chemotherapy in elderly patients with lung cancer
Scientific Title:Acronym
The study of systemic influence by chemotherapy in elderly patients with lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the systemic influence by chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of the lung, heart, liver,and renal functions before and after chemotherapy
Key secondary outcomes
The assessment of quality of life
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. lung cancer patients
2. stage IIIB or IV
3. the patients who recieve chemotherapy in our hospital.
4. adequate organ functions
5. obtained written informed consent
Key exclusion criteria
1. significant severe diseases
2. active infection
3. symptomatic brain metastases
4. mental or psychological disorder
5. history of severe allergic reaction to any medication
6. in pregnancy
7. patients who judged to be inappropriate by the attending doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kimura |
Organization
Osaka City University
Division name
Premier Preventive Medicine
Zip code
Address
ABENO HARUKAS 21F, 1-1-43, Abenosuji, abeno-ku, Osaka 545-6090 JAPAN
TEL
06-6624-4041
kimutats@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kimura |
Organization
Osaka City University
Division name
Premier Preventive Medicine
Zip code
Address
ABENO HARUKAS 21F, 1-1-43, Abenosuji, abeno-ku, Osaka 545-6090 JAPAN
TEL
06-6624-4041
Homepage URL
http://medcity21.jp/clinic/clinicalresearch.shtml
kimutats@med.osaka-cu.ac.jp
Sponsor or person
Institute
Premier Preventive Medicine, Graduate School of Medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research(S)or(C), Japan Society for the Promotion of Science(JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 06 | Month | 05 | 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
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
patient accrural period:
from July 2016 to March 2022
Management information
Registered date
| 2016 | Year | 06 | Month | 03 | Day |
Last modified on
| 2016 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026041
