UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027030
Receipt number R000030989
Scientific Title Assessment of reliability of small biopsy samples for tumor PD-L1 expression in non-small-cell lung cancer
Date of disclosure of the study information 2017/04/18
Last modified on 2019/01/15 20:28:07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Assessment of reliability of small biopsy samples for tumor PD-L1 expression in non-small-cell lung cancer

Acronym

PD-L1 expression in NSCLC with small biopsy samples

Scientific Title

Assessment of reliability of small biopsy samples for tumor PD-L1 expression in non-small-cell lung cancer

Scientific Title:Acronym

PD-L1 expression in NSCLC with small biopsy samples

Region

Japan


Condition

Condition

Non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Programmed death 1 immune checkpoint inhibitor antibody was effective for patients with PD-L1 positive advanced NSCLC. However, the potency was estimated using surgically resected specimens or core needle biopsy samples in past large clinical trials. The aim of this study is to prospectively investigate the reliability of small samples of NSCLC in determining the PD-L1 expression status.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

PD-L1 expression status of small samples with each procedure
(under rigid bronchoscopy, flexible bronchoscopy, CT & US-guided core-needle, excisional method)

Key secondary outcomes

1) Total number of tumor cells
2) Comparison of sample size, nunber of tumor cells and PD-L1 expression in BF 1T260 and BF P260F
3) Concordance rate of PD-L1 expression status in biopsy and surgical materials.
4) Efficacy for administration of PD-1 immune checkpoint inhibitor antibody


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 confirmed advanced non-small cell lung cancer (NSCLC)
2) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3) Patient with evaluable lesion based on RECIST
4) Written informed consent

Key exclusion criteria

Other cases attending physician it is determined unsuitable for registration of the study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name MASAMICHI MINESHITA

Organization

St. Marianna University School of Medicine

Division name

Division of Respiratory Diseases, Department of Internal Medicine

Zip code


Address

2-16-1 Sugao Miyamae-ku, Kawasaki 216-8511

TEL

044-977-8111

Email

m-mine@marianna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name KEI MORIKAWA

Organization

St. Marianna University School of Medicine

Division name

Division of Respiratory Diseases, Department of Internal Medicine

Zip code


Address

2-16-1 Sugao Miyamae-ku, Kawasaki 216-8511

TEL

044-977-8111

Homepage URL


Email

mokke5454@yahoo.co.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

St. Marianna University School of Medicine

Organization

Division

Category of Funding Organization

Other

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 04 Month 18 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

153 cases of PD-L1 expression were evaluated. 134 cases were sampled by bronchoscopy (111 EBUS-TBBs using BF-P260F/1T260 in 85/26 cases, 23 EBUS-TBNAs), and 19 were CT or US-guided core-needle biopsies. Tumor cell count and sample sizes were significantly larger for BF-1T260 than BF-P260F and EBUS-TBNA. Moreover, tumor cell counts for each subsequent biopsy decreased. The TPS (undiagnosed, under 1%, 1%-49%, over 50%) was 4/40/35/21% for EBUS-TBB using BF-P260F, 0/27/31/42% for using BF-1T260F, 0/22/26/52% for EBUS-TBNA, and 5/37/21/37% for CT or US-guided. In early stage adenocarcinoma, TPS was low. The concordance rate of TPS by biopsy and surgical materials was 86.7%.

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

2017 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

No longer recruiting.


Management information

Registered date

2017 Year 04 Month 18 Day

Last modified on

2019 Year 01 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030989


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name