UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008177 |
|---|---|
| Receipt number | R000009586 |
| Scientific Title | Japan molecular epidemiology lung cancer cases study |
| Date of disclosure of the study information | 2012/06/23 |
| Last modified on | 2014/12/16 14:52:43 |
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Basic information
Public title
Japan molecular epidemiology lung cancer cases study
Acronym
JME study
Scientific Title
Japan molecular epidemiology lung cancer cases study
Scientific Title:Acronym
JME study
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Surgical specimens, and clinical and life style information are collected prospectively.
Questionnaire is for detailed assessment of the following: Exposure to active and passive smoke: Occupational exposures: Reproductive and hormonal risk factors: Weight loss: Family smoking status: Medication use: Family history of cancer: Food and exercise.
1. Assess lung tissue from patients with stage I, stage II, stage IIIA, or stage IIIB non-small cell lung cancer for alterations in specific genes, including EGFR, Kras and ALK, and for expression of HER2 and estrogen receptors and for detection of Human Papilloma virus (HPV), and for exploring new molecular markers using a next generation DNA sequencer.
2. Determine whether the frequency of EGFR, Kras and ALK mutations differ in lung cancer between never smokers and ever-smokers males and females.
3. Determine whether the frequency of EGFR mutations is higher in never smokers with exposed long duration of passive smoke than those with short one, divided by the median duration.
4. Determine whether the detection rate of HPV is higher in the southern part region than the northern in Japan.
Basic objectives2
Others
Basic objectives -Others
1. Determine whether relapse rate, disease free survival and overall survival time differ among the patients with EGFR mutations, Kras and the any other.
2. Determine whether mutational profiles differ between Japanese and Americans adjusting by gender, smoking status, and other clinical and life style backgrounds.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Assess lung tissue from patients with stage I, stage II, stage IIIA, or stage IIIB non-small cell lung cancer for alterations in specific genes, including EGFR, Kras and ALK, and for expression of HER2 and estrogen receptors and for detection of Human Papilloma virus (HPV), and for exploring new molecular markers using a next generation DNA sequencer.
2. Determine whether the frequency of EGFR, Kras and ALK mutations differ in lung cancer between never smokers and ever-smokers males and females.
3. Determine whether the frequency of EGFR mutations is higher in never smokers with exposed long duration of passive smoke than those with short one, divided by the median duration.
4. Determine whether the detection rate of HPV is higher in the southern part region than the northern in Japan.
Key secondary outcomes
1. Determine whether relapse rate, disease free survival and overall survival time differ among the patients with EGFR mutations, Kras and the any other.
2. Determine whether mutational profiles differ between Japanese and Americans adjusting by gender, smoking status and other clinical backgrounds.
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
1. Histologically confirmed non-small cell lung cancer: Stage I, II, IIIA, or IIIB (T4 or N3) disease
Newly diagnosed disease: Must have tumor blocks/slides available and must be willing to provide tissue samples
2. Informed cnosent
3. Information of smoking history
4. Ability to answer questionnaire
Key exclusion criteria
1. Prior chemotherapy or radiotherapy
2. Other prior malignancy
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihide Matsumura |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Surgery
Zip code
Address
1180 Nagasone-cho, Kita-ku, Sakai, Osaka
TEL
072-252-3021
a-matsumura@kch.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Kawaguchi |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Internal Medicine
Zip code
Address
1180 Nagasone-cho, kita-ku, Sakai, Osaka
TEL
072-252-3021
Homepage URL
t-kawaguchi@kch.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
国立病院機構施設
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 01 | Day |
Other
Other related information
recruiting samples for 2 years, and follow up of the cases for 4 years
Management information
Registered date
| 2012 | Year | 06 | Month | 15 | Day |
Last modified on
| 2014 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009586
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
