UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001261 |
|---|---|
| Receipt number | R000001535 |
| Scientific Title | Prospective obervation of limited resection for compromized patients with stage I non-small cell lung cancer |
| Date of disclosure of the study information | 2008/07/22 |
| Last modified on | 2022/05/14 11:36:12 |
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Basic information
Public title
Prospective obervation of limited resection for compromized patients with stage I non-small cell lung cancer
Acronym
Prospective obervation of limited surgery for NSCLC
Scientific Title
Prospective obervation of limited resection for compromized patients with stage I non-small cell lung cancer
Scientific Title:Acronym
Prospective obervation of limited surgery for NSCLC
Region
| Japan |
Condition
Condition
Stage I non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess efficasy and safety of limited surgery for compromised patiets with non-small cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Over-all survival
Key secondary outcomes
Disease free survival
Pattern of relapse
Side effect
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)Patologically diagnosed non-small cell lung cancer
2)Stage I
3)PpoFEV1.0<800 or severe comorbidity
4)20yo<
5)Well infromed
Key exclusion criteria
1)GGO>75%
2)Active maligancy
3)Pchological problems
4)Inappropliate case juded by phygisian
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Sawabata |
Organization
Osaka University Graduate School of Medicine
Division name
General Thoracic Surgery
Zip code
560-0011
Address
(L-5)2-2 Yamadaoka, Suita
TEL
06-6879-3152
nsawabata@hotmail.com
Public contact
Name of contact person
| 1st name | NORIYOSHI |
| Middle name | |
| Last name | SAWABATA |
Organization
Kanetsu Lung Cancer Study Group
Division name
Office of Clinical Sudy
Zip code
634-8522
Address
2-2 yamadaoka suita osaka Japan
TEL
0744223051
Homepage URL
nsawabata@naramed-u.ac.jp
Sponsor or person
Institute
Kanetsu Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Kanetsu Lung Cancer Study Group
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
Kanetsu Lung Cancer Study Group
Address
1
Tel
1
nsawabata@hotmail.com
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
| 2008 | Year | 07 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2008 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At 1 Jun 2011, 16 cases.
Management information
Registered date
| 2008 | Year | 07 | Month | 22 | Day |
Last modified on
| 2022 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001535
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
