UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004914 |
|---|---|
| Receipt number | 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 12:51:01 |
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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
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
yuka@asahikawamc.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Asahikawa Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005563
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