UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020215 |
|---|---|
| Receipt number | R000023341 |
| Scientific Title | Japanese lung cancer registry study: Japanese joint committee of lung cancer registry database of patients who underwent resections in 2010 |
| Date of disclosure of the study information | 2015/12/18 |
| Last modified on | 2020/12/19 10:40:09 |
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Basic information
Public title
Japanese lung cancer registry study: Japanese joint committee of lung cancer registry database of patients who underwent resections in 2010
Acronym
Japanese lung cancer registry study: lung cancer registry database of surgical cases in 2010
Scientific Title
Japanese lung cancer registry study: Japanese joint committee of lung cancer registry database of patients who underwent resections in 2010
Scientific Title:Acronym
Japanese lung cancer registry study: lung cancer registry database of surgical cases in 2010
Region
| Japan |
Condition
Condition
Primary lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the clinicopathological features of resected primary lung cancer in a large registry population in Japan.
Basic objectives2
Others
Basic objectives -Others
These registration data will improve UICC TNM classification.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
A nationwide retrospective registry study on the prognosis and clinicopathological profiles of resected lung cancer in 2010
Key secondary outcomes
To identify predictive factors of surgical outcome for lung cancer
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
Patients who underwent pulmonary resections for primary lung cancer in 2010 at the teaching hospitals approved by the Japanese board of general thoracic surgery
Key exclusion criteria
Surgery for clinical staging
Transbronchial endoscopic surgery
Radiofrequency ablation or topical treatment by other technologies
Surgery for primary trachea cancer
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yoshino |
Organization
Chiba University Graduate School of Medicine
Division name
General Thoracic Surgery
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba
TEL
043-222-7171
1royoshino@gmail.com
Public contact
Name of contact person
| 1st name | Meinoshin |
| Middle name | |
| Last name | Okumura |
Organization
Osaka University Graduate School of Medicine
Division name
General Thoracic Surgery
Zip code
565-0871
Address
2-2-L5, Yamadaoka, Suita-city, Osaka
TEL
06-6879-3152
Homepage URL
https://haigan-touroku.jp/
haigan@thoracic.med.osaka-u.ac.jp
Sponsor or person
Institute
Japanese Joint Committee of Lung Cancer Registry
Institute
Department
Personal name
Funding Source
Organization
Japanese Joint Committee of Lung Cancer Registry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Center for Translational Research Osaka University Hospital
Address
Medical Center for Translational Research, 2-2, Yamadaoka, Suita-city, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.ac.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
呼吸器外科専門医合同委員会認定修練施設
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
https://haigan-touroku.jp/
Publication of results
Published
Result
URL related to results and publications
https://haigan-touroku.jp/
Number of participants that the trial has enrolled
18973
Results
The Japanese Joint Committee of Lung Cancer Registry (JJCLCR) has regularly conducted nationwide registry studies of lung cancer patients. The cohort consisted of 18,973 cases from 297 hospitals, which was the largest in the JJCLCR history. The most recent database of lung cancer surgery in Japan was successfully presented. Especially, as for long-term outcomes, overall survivals and disease-free survivals after surgery according to the TNM staging were shown.
Results date posted
| 2020 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The Japanese Joint Committee of Lung Cancer Registry has regularly conducted nationwide registry studies every 5-6 years. The most recent outcomes of lung cancer surgery and the validity of the recent revision of the TNM staging system were investigated.
Participant flow
The inclusion criteria were as follows: (1) pathological or cytological diagnosis of any type of primary lung cancer; and (2) surgery with curative intent between January 1 and December 31, 2010. The registry followed the ethical guidelines for epidemiologic studies and was approved by the review board of Osaka University Medical Hospital (approval no. 15321). The clinicopathologic profiles, staging, and prognosis of patients who underwent surgery for primary lung cancer in 2010 were collected in 2016 and analyzed for surgical outcomes.
Adverse events
N/A
Outcome measures
The cohort consisted of 18,973 cases from 297 hospitals. R0 resection was performed in 92.9%, and 30/90-day mortality rates were 0.43/1.26%. Overall/disease-free survival rates at 5 years were 74.7/67.8%. Five-year survival rates by c-stage (N=18,973)/p-stage (N=18,806) of ver.7 were: IA 83.5/88.9%, IB 72.2/76.7%, IIA 58.9/64.1%, IIB 54.3/56.1%, IIIA 48.9/47.9%, IIIB 40.1/30.2%, and IV 37.4/36.1%. The survival rates were improved in all pathological stages compared with those in 2004. Five-year survival rates by c-stage of ver.8 (N=16,143) were: O 97.0%, IA1 91.6%, IA2 81.4%, IA3 74.8%, IB 71.5%, IIA 60.2%, IIB 58.1%, IIIA 50.6%, IIIB 40.5%, IIIC 37.5%, and IVA/B 36.0%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Using clinical data from the registry in 2016 for cases of surgery performed in 2010, demographics, surgical results, and stage-specific prognoses will be analyzed.
Management information
Registered date
| 2015 | Year | 12 | Month | 16 | Day |
Last modified on
| 2020 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023341
| 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 |
