UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034488
Receipt No. R000039330
Scientific Title Investigation on exhaled nitrogen chemicals in lung cancer patients undergoing lobectomy
Date of disclosure of the study information 2018/10/15
Last modified on 2018/10/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Investigation on exhaled nitrogen chemicals in lung cancer patients undergoing lobectomy
Acronym Investigation on exhaled nitrogen chemicals in lung cancer patients undergoing lobectomy
Scientific Title Investigation on exhaled nitrogen chemicals in lung cancer patients undergoing lobectomy
Scientific Title:Acronym Investigation on exhaled nitrogen chemicals in lung cancer patients undergoing lobectomy
Region
Japan

Condition
Condition lobectomy
Classification by specialty
Chest surgery Anesthesiology Intensive care medicine
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For patients with lung cancer who undergo lobectomy, to measure the concentration of exhaled nitrogen chemicals (NO, NO2, HONO) at the perioperative period and to evaluate the effect of surgery. Also, to evaluate not only the relevance between collapsed lung and non-collapsed lung but also the relevance to blood ROS, blood cytokines, and pulmonary function.
Basic objectives2 Others
Basic objectives -Others epidemiology research
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes change in exhaled NO, NO2, HONO concentration during perioperative period
Key secondary outcomes 1) relevance of exhaled NO, NO2, HONO and collapsed lung and non-collapsed lungs during perioperative period
2) relevance of exhaled NO, NO2, HONO and blood ROS during perioperative period
3) relevance of exhaled NO, NO2, HONO and blood cytokines during perioperative period
4) relevance of exhaled NO, NO2, HONO and pulmonary function during perioperative period
5) relevance of exhaled NO, NO2, HONO and duration of collapse pulmonary during perioperative period

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) patients over 20 years at the time of obtaining informed consent
2) patients with lung cancer up to stage II
3) patients scheduled for lobectomy
4) patients with ASA PS 1 to 2
Key exclusion criteria 1) patients undergoing surgery requiring general anesthesia within 3 months prior to obtaining informed consent
2) patients with heart disease
3) patients with arrhythmia
4) patients with poor control hypertenson
5) patients with respiratory dysfunction
6) patients with lung disease
7) patients with smoking history within 3 months before consent acquisition
8) patients with pulmonary hypertension
9) diabetic patients with poor control
10) patients with cerebrovascular disorders
11) patients with severe liver disease
12) patients with severe kidney disease
13) patients with declining blood clotting ability
14) patients with thrombocytopenia
15) patients who receive chemotherapy, radiation therapy, immunotherapy within 3 months prior to obtaining informed consent
16) patients with systemically or locally active infections
17) highly obese patients
18) women who may be pregnant or have a possibility of pregnancy
19) patients who received study drugs or investigational drugs within 3 months prior to obtaining informed consent
20) patinets whom research investigator has determined to be inappropriate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazumi Funaki
Organization Tottori University
Division name Division of Anesthesiology and Critical Care Medicine
Zip code
Address 36-1, Nishi-cho, Yonago, Tottori, Japan
TEL 0859-38-6657
Email funapon1116@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazumi Funaki
Organization Tottori University
Division name Division of Anesthesiology and Critical Care Medicine
Zip code
Address 36-1, Nishi-cho, Yonago, Tottori, Japan
TEL 0859-38-6657
Homepage URL
Email funapon1116@gmail.com

Sponsor
Institute Division of Anesthesiology and Critical Care Medicin, Tottori University
Institute
Department

Funding Source
Organization Division of Anesthesiology and Critical Care Medicin, Tottori University
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
Address
Tel
Email

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 鳥取大学医学部附属病院(鳥取県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 15 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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information For patients with lung cancer who undergo lobectomy, to measure the concentration of exhaled nitrogen chemicals (NO, NO2, HONO) at the perioperative period and to evaluate the effect of surgery. Also, to evaluate not only the relevance between collapsed lung and non-collapsed lung but also the relevance to blood ROS, blood cytokines, and pulmonary function.

Management information
Registered date
2018 Year 10 Month 14 Day
Last modified on
2018 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039330

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.