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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004914
Receipt No. R000005563
Scientific Title Validity of Sputum Induction Method for the Diagnosis of Lung Cancer
Date of disclosure of the study information 2011/01/21
Last modified on 2015/02/03

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Basic information
Public title Validity of Sputum Induction Method for the Diagnosis of Lung Cancer
Acronym Sputum Induction in Patients with Lung Cancer
Scientific Title Validity of Sputum Induction Method for the Diagnosis of Lung Cancer
Scientific Title:Acronym Sputum Induction in Patients with Lung Cancer
Region
Japan

Condition
Condition Patients with suspected lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We aimed to evaluate the efficacy of induced sputum obtained by inhalation of hypertonic saline for 15 minutes, for the diagnosis of lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sputum expectoration rate
Key secondary outcomes 1. Cytological examination of sputum induced by 10% hypertonic saline
2. Analysis of adverse events arising from the inhalation of 10% hypertonic saline
3. Testing of the lung carcinoma cells for EGFR gene mutation in sputum cytology-positive cases and comparison of the test results between spontaneous and induced sputum specimens
4. Questionnaire survey of the patients.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Spontaneous sputum cytology specimens were collected from each subject for 3 days after registration. On each day during the subsequent 3-day period, each subject was asked to inhale nebulized 10% hypertonic saline (mixed with 0.5 mL salbutamol), in an attempt to induce sputum. Immediately before each session of sputum induction, the oral cavity was cleared of food residues and mucus. During the 15-minute saline inhalation, sputum was collected in a sterile dish. Three slides were prepared from each sputum sample, fixed in 95% ethanol, and stained with Papanicolaou method. After completion of the protocol, all patients fulfilled a questionnaire containing 4 questions on the induction procedures.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with suspected lung cancer based on the detection of an abnormal opacity on the chest X-ray. Written informed consent
Key exclusion criteria (1) patients with uncontrolled asthma, (2) patients with severe hepatopathy, nephropathy, cardiac disease or hematological disease, or other serious complications, (3) pregnant or possibly pregnant women, and (4) other patients judged by the physician as being unsuitable candidates for the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuka Fujita
Organization National Hospital Organization Asahikawa Medical Center
Division name Clinical Reseach
Zip code
Address 7 Hanasaki-cho Asahikawa Hokkaido 070-8644 Japan
TEL 0166-51-3161
Email yuka-1@hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuka Fujita
Organization National Hospital Organization Asahikawa Medical Center
Division name Respiratory Medicine
Zip code
Address 7 Hanasaki-cho Asahikawa Hokkaido 070-8644 Japan
TEL 0166-51-3161
Homepage URL
Email yuka@asahikawamc.hosp.go.jp

Sponsor
Institute National Hospital Organization Asahikawa 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
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 国立病院機構旭川医療センター

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 21 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 Enrolling by invitation
Date of protocol fixation
2009 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2013 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 20 Day
Last modified on
2015 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005563

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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