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

Email

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


Email

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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034228


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name