UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015830 |
|---|---|
| Receipt number | R000018417 |
| Scientific Title | Circulating tumor cells for EGFR-TKI resistance in NSCLC patients; prospective, multicenter study |
| Date of disclosure of the study information | 2014/12/03 |
| Last modified on | 2018/03/01 09:48:40 |
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Basic information
Public title
Circulating tumor cells for EGFR-TKI resistance in NSCLC patients; prospective, multicenter study
Acronym
CTC for EGFR-TKI resistance in NSCLC
Scientific Title
Circulating tumor cells for EGFR-TKI resistance in NSCLC patients; prospective, multicenter study
Scientific Title:Acronym
CTC for EGFR-TKI resistance in NSCLC
Region
| Japan |
Condition
Condition
Non small cell lung carcinoma with EGFR mutation
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To detect the EGFR-TKI resistance using circulating tumor cells.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The frequency of detecting T790M in CTC
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.NSCLC with EGFR mutation(Ex.18,19,21)
2.Kick off the Gefitinib
3.Having the detectable taget (>10mm)
4.Getting the informed consent
Key exclusion criteria
1. HIV, HBV, HCV
2. History of Gefitinib, Erlotinib and crizotinib
3. Symptomatic brain metastasis
4. Presence of pulmonary fibrosis or interstitial pneumonia in chest CT
5. Active double cancer
6. Primary physician considered not to be suitable for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Matsutani |
Organization
Teikyo University School of Medicine
Division name
Surgery
Zip code
Address
2-11-1 Kaga, Itabashi-ku Tokyo
TEL
03-3964-1231
matsutan@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Matsutani |
Organization
Teikyo University School of Medicine
Division name
Surgery
Zip code
Address
2-11-1 Kaga, Itabashi-ku Tokyo, Japan
TEL
03-3964-1231
Homepage URL
matsutan@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Teikyo university school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nihon University
Tokyo Metropolitan Geriatric Hospital
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
帝京大学（東京都）
日本大学（東京都）
東京都健康長寿医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 03 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Chest CT, tumor marker and sample blood for each 3 month
Management information
Registered date
| 2014 | Year | 12 | Month | 03 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018417
