UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study of the surgery for lung cancer in patients with low pulmonary function
Acronym	A prospective observational study of the surgery for lung cancer in patients with low pulmonary function
Scientific Title	A prospective observational study of the surgery for lung cancer in patients with low pulmonary function
Scientific Title:Acronym	A prospective observational study of the surgery for lung cancer in patients with low pulmonary function
Region	Japan

Condition
Condition	Primary lung cancer, Chronic Obstructive Lung Disease (COPD)
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will investigate the surgery of lung cancer in patients with chronic obstructive pulmonary disease (COPD). And, we will perform this study with "Exploratory randomized trial of evaluation for Tiotropium in lung cancer surgery (UMIN000012217)" at the same time.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1- year overall survival
Key secondary outcomes	1)Rate of cardiopulmonary complications after surgery 2)Detail of cardiopulmonary complications after surgery 3)Rate of post operative complications excluding cardiopulmonary complications 4)Improvement of pulmonary function before and after using of drugs for COPD 5)Evaluation of the postoperative complications using the Clavien-Dindo classification 6)3-years overall survival 7)Rate of adverse events 8)Evaluation of postoperative compliance

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) Clinically suspected primary lung cancer. 2) Postbronchodilator FEV1/FVC (forced expiratory volume in 1s/forced vital capacity) < 0.70 assessed by spirometry. 3) Resectable cancer lesion by surgery less than single lobectomy. 4) Without previously treatment for bronchial asthma. 5) No past pulmonary resection excluding wedge resection. 6) Patients stopping smoking at the time of giving the consent to this study. 7) Adequate organ function tolerable for the general anesthesia. 8) Age of 20 years or older. 9) ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0, 1, 2. 10) Written informed consent to participate.
Key exclusion criteria	1) Median sternotomy. 2) Combined resection of the chest wall excluding parietal pleura excision. 3) History of active infection. 4) Active double cancer within 5 years of disease-free interval, except for curable lesions like carcinoma in situ and mucosal cancer. 5) Patients with glaucoma. 6) Patients with dysuria. 7) History of hypersensitivity to atropine or drugs similar to atropine. 8) Patients with interstitial pneumonia or pulmonary fibrosis. 9) Patients with arrhythmia requiring antiarrhythmic continuously. 10) Patients with thyropathy. 11) Patients with renal dysfunction needs blood purification therapy. 12) Patients with psychiatric disease. 13) Patients requiring systemic steroids medication. 14) Patients with uncontrolled diabetes mellitus. 15) Patients with uncontrolled hypertension. 16) Current or previous within the last 6 months history of severe heart diseases, cerebrovascular disease. 17) The pregnant and lactating female , female who has possibility of the pregnancy. 18) Patients who were judged inappropriate to entry this study by physician.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tsuboi Middle name Last name Masahiro
Organization	National Cancer Center Hospital East
Division name	Thoracic Surgery
Zip code	277-8577
Address	6-5-1 kashiwanoha, Kashiwa City, 277-8577, Japan
TEL	04-7133-1111
Email	mtsuboi@za2.so-net.ne.jp

Public contact
Name of contact person	1st name Teppei Middle name Last name Nishii
Organization	Yokohama City University Medical Center
Division name	Thoracic Surgery
Zip code	232-0024
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	nteppei@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
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	Yokohama City University Ethics Committee
Address	3-9 Fukuura,Kanazawa-ku,Yokohama 236-0004 Japan
Tel	0453707629
Email	nextjim1@yokohama-cu.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	横浜市立大学附属市民総合医療センター（神奈川県） 神奈川県立がんセンター（神奈川県） 順天堂大学医学部附属順天堂医院（東京都） 広島大学病院（広島県） 国立がん研究センター東病院（千葉県） 千葉県がんセンター（千葉県） 近畿大学医学部附属病院（大阪府） 東京医科大学病院（東京都） 聖マリアンナ医科大学病院（神奈川県） 産業医科大学病院（福岡県） 山口大学医学部附属病院（山口県） 新潟県立がんセンター新潟病院（新潟県） 倉敷中央病院（岡山県）

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 24 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	152
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	2013 Year 12 Month 15 Day
Date of IRB	2014 Year 01 Month 23 Day
Anticipated trial start date	2014 Year 02 Month 24 Day
Last follow-up date	2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will investigate the surgery of lung cancer in patients with chronic obstructive pulmonary disease (COPD). And, we will perform this study with "Exploratory randomized trial of evaluation for Tiotropium in lung cancer surgery (UMIN000012217)" at the same time.

Management information
Registered date	2014 Year 02 Month 24 Day
Last modified on	2022 Year 03 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015443