UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015732 |
|---|---|
| Receipt number | R000018307 |
| Scientific Title | Observational Study of Postoperative Treatment in the Cases of Complete Excision for Non-Small-Cell Lung Cancer of Pathological Stage I (T1>2 cm, TNM Classification Version 6) |
| Date of disclosure of the study information | 2014/11/21 |
| Last modified on | 2018/10/12 13:40:13 |
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Basic information
Public title
Observational Study of Postoperative Treatment in the Cases of Complete Excision for Non-Small-Cell Lung Cancer of Pathological Stage I (T1>2 cm, TNM Classification Version 6)
Acronym
POPCORN: Post-Operative Patterns of Care and Outcome: a Retrospective analysis of patients with early-stage NSCLC
Scientific Title
Observational Study of Postoperative Treatment in the Cases of Complete Excision for Non-Small-Cell Lung Cancer of Pathological Stage I (T1>2 cm, TNM Classification Version 6)
Scientific Title:Acronym
POPCORN: Post-Operative Patterns of Care and Outcome: a Retrospective analysis of patients with early-stage NSCLC
Region
| Japan |
Condition
Condition
Advanced lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study consists of the following two studies.
Study A: Among the patients with non-small-cell lung cancer of the pathological stage I (T1>2 cm, TNM Classification Version 6) whose lesion has been completely excised, those who have not participated in the clinical study of postoperative treatment will be selected as the subjects, and the items investigated upon enrollment (including those related to prognosis), including the patients' background and the reason why they did not participate in the clinical study, will be mainly analyzed.
Study B: The long-term prognosis will be examined (at least 5 years) after enrollment in Study A, and the results will be compared with the data for those who have participated in the clinical study of postoperative treatment, which have been obtained in a different study.
Basic objectives2
Others
Basic objectives -Others
adverse event
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Study A
Reasons why the subjects have not been enrolled in the clinical study and the percentages
Study B
Overall survival
Key secondary outcomes
Study A
･Patient backgrounds
･Treatment implementation rate, contents of treatment, adherence
･Overall survival time
･Disease specific survival
･Correlations among above endpoints
Study B
･Disease specific survival
･Patient backgrounds
･Treatment implementation rate, adherence
･Correlations among above endpoints
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
Among the patients with non-small-cell lung cancer which has been completely excised by surgical lung lobectomy or more extensive surgical resection and lymph node dissection/selective lymph node dissection of at least ND2a, and has been diagnosed as Pathological Stage I (T1>2 cm, TNM classification, Version 6) during the period from the starting month at each site, as defined elsewhere, to December 31, 2013, those who have not been enrolled in the clinical study of postoperative treatment will be selected as the subjects.
Key exclusion criteria
No
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Kunitoh |
Organization
Japanese Red Cross Medical Center
Division name
Division of Chemotherapy
Zip code
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo 150-8935, Japan
TEL
03-3400-1311
no@mail
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamao |
Organization
Public Health Research Foundation
Division name
Comprehensive Support Project for Oncology Research
Zip code
Address
1-1-7, Nishiwaseda, Shinjuku-ku, Tokyo, 169-0051, Japa
TEL
03-5287-2633
Homepage URL
http://www.csp.or.jp/
info@csp.or.jp
Sponsor or person
Institute
LC-03 Executive committee
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
国立病院機構仙台医療センター
東北大学病院
茨城県立中央病院・茨城県地域がんセンター
栃木県立がんセンター
群馬県立がんセンター
国立がん研究センター東病院
千葉大学大学院医学研究院
国立がん研究センター中央病院
杏林大学医学部
東京医科大学病院
がん・感染症センター都立駒込病院
がん研究会有明病院
順天堂大学医学部附属順天堂医院
神奈川県立病院機構神奈川県立がんセンター
横浜市立大学附属市民総合医療センター
新潟県立がんセンター新潟病院
金沢大学附属病院
静岡県立静岡がんセンター
愛知県がんセンター中央病院
名古屋大学大学院医学系研究科
京都大学医学部附属病院
大阪府立病院機構大阪府立成人病センター
大阪府立病院機構大阪府立呼吸器・アレルギー医療センター
大阪市立総合医療センター
兵庫県立がんセンター
倉敷中央病院
岡山大学病院
国立病院機構呉医療センター・中国がんセンター
広島大学病院
国立病院機構四国がんセンター
国立病院機構九州がんセンター
長崎大学病院
熊本大学医学部附属病院
熊本中央病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
http://www.csp.or.jp
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
relapse-free-survival
Management information
Registered date
| 2014 | Year | 11 | Month | 21 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018307
| 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 |
