UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000029661
Receipt number	R000033363
Scientific Title	Imaging biomarker of acute exacerbation of interstitial pneumonia after surgical resection of lung cancer
Date of disclosure of the study information	2017/10/26
Last modified on	2021/04/16 18:08:41

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Basic information

Public title

Imaging biomarker of acute exacerbation of interstitial pneumonia after surgical resection of lung cancer

Acronym

Imaging biomarker of AE of IP after resection of lung cancer

Scientific Title

Imaging biomarker of acute exacerbation of interstitial pneumonia after surgical resection of lung cancer

Scientific Title:Acronym

Imaging biomarker of AE of IP after resection of lung cancer

Region

Japan

Condition

Patients with lung cancer and interstitial pneumonia

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

The purpose of this study is to determine imaging biomarker for the acute exacerbation in patients with lung cancer and interstitial pneumonia after surgical resection .

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

Correlation of acute exacerbation of interstitial pneumonia (IP) with the following; pattern of IP, degree of IP, degree of emphysema, diameter of the pulmonary trunk, lung volume

Key secondary outcomes

Correlation of acute exacerbation of IP with the extent of honeycomb, ground glass opacity, consolidation, and blood chemistry study, pulmonary function test, the surgical procedure, preoperative medicine use

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) the patients aged 20 years and over
2) the patients who underwent HRCT within 30 days before the resection of lung cancer

Key exclusion criteria

The patients whom the doctor in attendance judged to be unsuitable as a subject of the examination

Target sample size

360

Research contact person

Name of lead principal investigator

1st name Yoshiyuki

Middle name

Last name Ozawa

Organization

Nagoya City University

Division name

Graduate School of Medical Sciences, Department of Radiology

Zip code

4678601

Address

1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Japan

TEL

0528538276

Email

yoshioza@med.nagoya-cu.ac.jp

Public contact

Name of contact person

1st name Kazuhiro

Middle name

Last name Nakayasu

Organization

Kondo photo process co.

Division name

medical section

Zip code

5430011

Address

11-15, shimizudani-cho, tennnouji-ku, osaka, Japan

TEL

06-4303-4913

Homepage URL

Email

uu-360@rinsho-kenkyu.org

Sponsor or person

Institute

Department of Radiology, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name

Funding Source

Organization

Bayer

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

clinical research management center, Nagoya city university hospital

Address

1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Japan

Tel

0528587215

Email

clinical_research@med.nagoya-cu.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 26 Day

Related information

URL releasing protocol

https://www.ajronline.org/doi/abs/10.2214/AJR.21.25499

Publication of results

Published

Result

URL related to results and publications

https://www.ajronline.org/doi/abs/10.2214/AJR.21.25499

Number of participants that the trial has enrolled

Results

On preoperative CT, UIP pattern was present in 58% of AE group versus 74% in no-AE group (p=.16). In an only CT features model, independent predictors of AE were GGO extent (OR=2.8), consolidation extent (OR=9.4), and pulmonary trunk diameter (OR=4.2). This model achieved AUC 0.75, PPV 71%, and NPV 77% for AE. When combing CT and clinical variables, undergoing segmentectomy or more extensive surgery also independently predicted AE (OR=8.2; p=.02).

Results date posted

2021 Year 04 Month 16 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Lung cancer patients with interstitial pneumonia
Total: 78 men and 14 women, mean age 72 years
AE group (n=31): 28 men and 2 women, mean age 69 years
no-AE group (n=61): 50 men and 11 women, mean age 73 years.

Participant flow

The participants were selected by the following criteria:
1) Diagnosed with lung cancer and IP, 2) Underwent thoracic surgery for lung cancer between January 2010 and September 2016,3) Underwent thin-section CT within 30 days before lung surgery, 4) Over 20 years old.
33 AE group and 66 no-AE group were included. Then, 7 participants were excluded because poor quality of images. Finally, 31 AE group and 61 no-AE group were included.

Adverse events

no adverse events

Outcome measures

Primary outcomes
-UIP pattern:18 cases (58%) in AE group, 45 cases(74%) in no-AE group (p=0.16).

Data of AE and no-AE groups are expressed as mean, SD, respectively.
-Honeycomb extent (%): 3.5, 3.9 vs 4.6, 5.0 (p=0.35)
-Reticular opacity extent (%): 6.8, 4.3 vs 6.6, 4.1 (p>.99)
-GGO extent (%): 6.3, 5.4 vs 3.9, 3.8 (p=0.03)
-Consolidation extent (%): 0.5, 1.2 vs 0.1, 0.3 (p=0.009)
-Emphysema score: 6.0, 5.1 vs 5.6, 5.4 (p=0.72)
-Diameter of the Pulmonary trunk (mm): 28, 4 vs 26, 3(p=0.02)

Secondary outcomes
<Laboratory data>
-KL-6 (U/mL): 678, 351 vs 747, 470 (p=0.84)
-SPD (ng/mL):148, 86 vs 170, 25 (p=0.98)
-SPA (ng/mL): 46, 25 vs 68, 43 (p=0.08)
-LDH (IU/L): 217, 49 vs 217, 34 (p=0.70)
-CRP (mg/dL): 1.1, 1.8 vs 0.90, 2.6 (p=0.24)
-Leucocytes (1000/uL): 6.6, 1.6 vs 7.6, 2.3 (p=0.03)
<Pulmonary function test>
-%VC(%): 85, 17 vs 97, 18 (p=0.001)
-FVC(L): 2.8, 0.7 vs 3.0, 0.7 (p=0.11)
-FEV1(L): 2.1, 0.5 vs 2.3, 0.5 (p=0.14)
-%FEV1(%): 80, 8.6 vs 82, 14 (p=0.78)
-DLCO(mL/min/mmHg): 11, 3 vs 13, 6 (p=0.53)
<Others>
-VATS: 13 case (42%) vs 37 cases (61%) (p=0.12)
-Wedge resection/ segmentectomy or more: 2 cases(6%)/29 cases(94%) vs 15 cases(25%)/46 cases(75%)(p=0.046)
-Preoperative steroid medication: 2 cases(7%) vs 9 cases(15%)(p=0.32)

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 08 Month 15 Day

Date of IRB

2017 Year 08 Month 15 Day

Anticipated trial start date

2017 Year 08 Month 15 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

The analysis of the obtained data at multi-institutional collaboration study was completed.

Management information

Registered date

2017 Year 10 Month 22 Day

Last modified on

2021 Year 04 Month 16 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033363

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name