UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029974 |
|---|---|
| Receipt number | R000034228 |
| Scientific Title | Prospective Study of the efficacy of Re-biopsy Using the Cryoprobe in Detection of EGFR-T790M Mutation After EGFR-TKI Failure |
| Date of disclosure of the study information | 2017/11/30 |
| Last modified on | 2019/03/31 18:44:12 |
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Basic information
Public title
Prospective Study of the efficacy of Re-biopsy Using the Cryoprobe in Detection of EGFR-T790M Mutation After EGFR-TKI Failure
Acronym
Re-biopsy by Cryo
Scientific Title
Prospective Study of the efficacy of Re-biopsy Using the Cryoprobe in Detection of EGFR-T790M Mutation After EGFR-TKI Failure
Scientific Title:Acronym
Re-biopsy by Cryo
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of re-biopsy using the cryoprobe in detection of EGFR-T790M mutation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic yield of histology specimens (success rate for re-biopsy)
Key secondary outcomes
EGFR-T790M detection rate
Time required for examination procedure
Incidence of adverse effects
Tissue areas of biopsies
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Re-biopsy using the cryoprobe
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. Patients who confirmed EGFR mutation-positive NSCLC histologically or cytologically and achieved progressive disease on EGFR-TKI treatment who need to access re-biopsy
2. 20 years old or older
3. Informed consent
Key exclusion criteria
1. Poor general condition
2. Lesion located adjacent to the visceral pleura, bulla and large vessel and had high risk of pneumothorax and bleeding on chest CT
3. Lesion located difficult to approach on chest CT
4. Re-examination following prior failure in this trial
5. Patients who need to access non-target lesion by bronchoscopic procedures in the same setting
6. Bleeding tendency
7. Pregnancy
8. Other clinical difficulties in this trial
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Uchino |
Organization
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Division name
Department of Pulmonary Medicine
Zip code
Address
Kajiicho465, Kawaramachi-Hirokoji, Kamigyo-ku Kyoto 602-8566, Japan
TEL
075-251-5513
uchino@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Imabayashi |
Organization
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Division name
Department of Pulmonary Medicine
Zip code
Address
Kajiicho465, Kawaramachi-Hirokoji, Kamigyo-ku Kyoto 602-8566, Japan
TEL
075-251-5513
Homepage URL
imabayas@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 15 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034228
