UMIN-CTR Clinical Trial

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
Email	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/
Email	haigan@thoracic.med.osaka-u.ac.jp

Sponsor
Institute	Japanese Joint Committee of Lung Cancer Registry
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023341