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 |
Japan molecular epidemiology lung cancer cases study
JME study
Japan molecular epidemiology lung cancer cases study
JME study
Japan |
non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
YES
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.
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.
Exploratory
Explanatory
Not applicable
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.
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.
Observational
Not applicable |
Not applicable |
Male and Female
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
1. Prior chemotherapy or radiotherapy
2. Other prior malignancy
900
1st name | |
Middle name | |
Last name | Akihide Matsumura |
National Hospital Organization Kinki-chuo Chest Medical Center
Surgery
1180 Nagasone-cho, Kita-ku, Sakai, Osaka
072-252-3021
a-matsumura@kch.hosp.go.jp
1st name | |
Middle name | |
Last name | Tomoya Kawaguchi |
National Hospital Organization Kinki-chuo Chest Medical Center
Internal Medicine
1180 Nagasone-cho, kita-ku, Sakai, Osaka
072-252-3021
t-kawaguchi@kch.hosp.go.jp
National Hospital Organization
National Hospital Organization
Japan
NO
国立病院機構施設
2012 | Year | 06 | Month | 23 | Day |
Partially published
No longer recruiting
2012 | Year | 06 | Month | 08 | Day |
2012 | Year | 07 | Month | 01 | Day |
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 04 | Month | 01 | Day |
2018 | Year | 04 | Month | 01 | Day |
2018 | Year | 04 | Month | 01 | Day |
recruiting samples for 2 years, and follow up of the cases for 4 years
2012 | Year | 06 | Month | 15 | Day |
2014 | Year | 12 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009586