UMIN-CTR Clinical Trial

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
Last 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
Email	uchino@koto.kpu-m.ac.jp

Public contact
1st 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
Email	imabayas@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine Graduate School of Medical Science
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034228