UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038648 |
|---|---|
| Receipt number | R000044036 |
| Scientific Title | Analysis of EGFR mutation using highly sensitive droplet digital PCR in non-small cell lung cancer patients with EGFR mutations. |
| Date of disclosure of the study information | 2019/11/22 |
| Last modified on | 2023/05/31 22:06:52 |
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Basic information
Public title
Analysis of EGFR mutation using highly sensitive droplet digital PCR in non-small cell lung cancer patients with EGFR mutations.
Acronym
Analysis of EGFR mutation using highly sensitive droplet digital PCR in non-small cell lung cancer patients with EGFR mutations.
Scientific Title
Analysis of EGFR mutation using highly sensitive droplet digital PCR in non-small cell lung cancer patients with EGFR mutations.
Scientific Title:Acronym
Analysis of EGFR mutation using highly sensitive droplet digital PCR in non-small cell lung cancer patients with EGFR mutations.
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Quantitative analisis of EGFR T790M mutation by highly sensitive droplet digital PCR
Basic objectives2
Others
Basic objectives -Others
We analyze quantitative EGFR T790M mutation by highly sensitive droplet digital PCR between pre and post EGFR-TKIs treatment in non-small cell lung cancer patients with EGFR mutations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the quantity of T790M clones between pre and post EGFR-TKIs treatment
Key secondary outcomes
Detection of resistant mechanism, response rate, progression free survival
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
1)Pathologically proven non-small cell lung cancer.
2)EGFR-TKIs naive patients with relapsed disease or advance stage (III or IV).
3)EGFR mutations positive.
4)Available of tumor tissues or cytologically samples for DNA extraction.
5)Expected survival more than 90 days.
6)ECOG Performance status 0-1.
7)Meets all following laboratory data
Nt>=1000/mm3
Hb>=9.0g/dl
Plt>=10x10^4/mm3
AST, ALT<=100IU/L
T-Bil<=1.5mg/dL
Cr<=2.0mg/dL
SpO2<=90%(room air)
8)More than 20 years old on the enrollment day.
9)Patients with written informed consent.
Key exclusion criteria
1)Patients cannot ingest EGFR-TKIs.
2)Patients with paresis of intestine or ileus of intestine.
3)With chronic diarrhea.
4)Interstitial pulmonary disease, drug-induced interstitial pulmonary disease and irradiation pneumonitis clearly detected by chest CT.
5)Uncontrollable pleural/ abdominal/ pericardial effusion.
6)Symptomatic brain metastasis required for radiation therapy or surgical resection.
7)Patients with a radiation therapy included lung field within 28 days before enrollment.
8)Active infection to need systemic treatment.
9)Patients with severe complications (bleeding of digestive tract, heart disease, glaucoma, diabetes, etc.).
10)Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom.
11)Patients with pregnant or possibly pregnant, nursing.
12)Any other patients regarded as unsuitable for this study by the investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shhinnosuke |
| Middle name | |
| Last name | Takemoto |
Organization
Nagasaki University Hospital
Division name
Department of Respiratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7273
shinnosuke-takemoto@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Takemoto |
Organization
Nagasaki University Hospital
Division name
Department of Respiratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7273
Homepage URL
shinnosuke-tgakemoto@umin.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
095-819-7726
gaibushikin@ml.nagasaki-u.ac.jp
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
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 22 | 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
5
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
| 2019 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 11 | Month | 20 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044036
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