UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016756 |
|---|---|
| Receipt number | R000019441 |
| Scientific Title | Multi-institutional cohort study of evaluating safety and efficacy of surgical treatment for elderly lung cancer |
| Date of disclosure of the study information | 2015/03/09 |
| Last modified on | 2019/03/13 12:30:06 |
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Basic information
Public title
Multi-institutional cohort study of evaluating safety and efficacy of surgical treatment for elderly lung cancer
Acronym
cohort study of surgery for elderly lung cancer
Scientific Title
Multi-institutional cohort study of evaluating safety and efficacy of surgical treatment for elderly lung cancer
Scientific Title:Acronym
cohort study of surgery for elderly lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluating correlation between comprehensive assessment of elderly patients, morbidity and prognosis in elderly lung cancer patients who underwent surgical treatment
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safetly
Key secondary outcomes
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
| 75 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Lung cancer patients of 75 years old and more who underwent surgical treatment
Key exclusion criteria
Nothing
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Hiroshige |
| Middle name | |
| Last name | Nakamura |
Organization
Tottori University
Division name
General Thoracic Surgery
Zip code
683-8504
Address
36-1 Nishi-cho, Yonago, Tottori 683-8504, Japan
TEL
0859-38-6737
hnaka@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Saji |
Organization
St. Marianna University School of Medicine
Division name
Chest Surgery
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
saji-q@ya2.so-net.ne.jp
Sponsor or person
Institute
Chest Surgery, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna Univ. IRB
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
0449778111
saji-q@ya2.so-net.ne.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 | 03 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/29240884
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29240884
Number of participants that the trial has enrolled
1019
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
under writing
Management information
Registered date
| 2015 | Year | 03 | Month | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019441
