UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026803 |
|---|---|
| Receipt number | R000030771 |
| Scientific Title | Mass spectrometry-based proteogenomic investigation of protein-protein interaction networks and cancer-related pathways associated with NSCLC patients' EGFRm (+/-) status |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2020/08/06 18:14:38 |
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Basic information
Public title
Mass spectrometry-based proteogenomic investigation of protein-protein interaction networks and cancer-related pathways associated with NSCLC patients' EGFRm (+/-) status
Acronym
MS-based Proteogenomic study on molecular networks associated with EGFRm (+/-) status
Scientific Title
Mass spectrometry-based proteogenomic investigation of protein-protein interaction networks and cancer-related pathways associated with NSCLC patients' EGFRm (+/-) status
Scientific Title:Acronym
MS-based Proteogenomic study on molecular networks associated with EGFRm (+/-) status
Region
| Japan |
Condition
Condition
Non-small cell lung cancer (NSCLC)
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify proteins expressed and their associated protein-protein interaction (PPI) networks / pathways significant to EGFR mutations positive and negative.
Basic objectives2
Others
Basic objectives -Others
To attain information of molecular networks associated with EGFR(+/-) status of NSCLC patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of disease-related expressed proteins associated with the presence or absence of EGFR mutation and extraction of their molecular interaction networks
Key secondary outcomes
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
Cases which were diagnosed pathologically a primary lung adenocarcinoma and the presence or absence of EGFR mutation was clarified.
Eastern Cooperative Oncology Group (ECOG)PS: 0 to 2
Key exclusion criteria
The case where patient's consent was withdrawn.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Saji |
Organization
St. Marianna University School of Medicine
Division name
Chest Surgery
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
h-nakamura@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuko Shimamura |
Organization
St. Marianna University School of Medicine
Division name
Translational Medicine Informatics
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
shimamura@marianna-u.ac.jp
Sponsor or person
Institute
Chest Surgery, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit 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
聖マリアンナ医科大学 Dept. Translational Medicine
分子病態情報講座 （神奈川県） Informatics, St Marianna U. School of Medicine
(Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 10 | 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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Among cases that were pathologically confirmed as primary lung non - small cell lung cancer and were detected on the presence or absence of EGFR gene mutation, EGFR mutation positive 25 cases and negative 25 cases will be randomly taken. Furthermore, among the 25 positive EGFR mutations, when PD (progressive disease) and drug resistance were observed for the cases that administration of 1 / 2th generation EGFR-TKI, then tumor biopsies will be again obtained in order to perform further in-depth protein analysis.
Management information
Registered date
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2020 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030771
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
