UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000056974
Receipt number	R000064993
Scientific Title	Exploring the molecular biology, prognosis, and therapeutic approaches in recurrent or advanced primary Salivary Gland-Type Tumors of the Lung and Trachea: A Multicenter Retrospective Observational Study (NEJ068)
Date of disclosure of the study information	2025/02/07
Last modified on	2025/02/07 19:33:16

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Basic information

Public title

Exploring the molecular biology, prognosis, and therapeutic approaches in recurrent or advanced primary Salivary Gland-Type Tumors of the Lung and Trachea: A Multicenter Retrospective Observational Study (NEJ068)

Acronym

NEJ068

Scientific Title

Scientific Title:Acronym

NEJ068

Region

Japan

Condition

Primary Salivary Gland-Type Tumors of the Lung and Trachea

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

The aim of this study is to enhance the understanding of this rare disease by retrospectively analyzing the molecular biological background, prognosis, and treatment outcomes of recurrent or advanced-stage salivary gland-type tumors originating in the lung and trachea. This research seeks to provide a foundation for developing better therapeutic strategies.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

For all cases; Molecular biological investigations (driver gene mutations, PD-L1 expression)
For cases receiving drug therapy; Progression-free survival

Key secondary outcomes

For all cases; Overall survival
For cases receiving drug therapy; Objective response rate, Disease control rate, and safety
Treatment details; Local treatments (surgical treatment, radiotherapy, stent placement, interventional treatments, etc.), Drug therapies (chemotherapy, molecular targeted therapies, immune checkpoint inhibitors, etc.), Best supportive care

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria will be included in the study;
1 Cases pathologically confirmed as salivary gland-type tumors through histological diagnosis.
2 Cases with clinical stage IIIA or higher that are deemed unresectable by curative surgical intervention, or cases of recurrence following surgical resection or definitive (chemo)radiotherapy.
3 Cases diagnosed as recurrent or advanced stage between January 1, 1981, and December 31, 2023.

Key exclusion criteria

Patients who meet any of the following criteria will be excluded from the study;
1 Cases with a primary lesion originating in organs other than the lung or trachea.
2 Cases deemed inappropriate for inclusion by the researchers.

Target sample size

120

Research contact person

Name of lead principal investigator

1st name Takehito

Middle name

Last name Shukuya

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Respiratory Medicine

Zip code

113-8421

Address

3-1-3 Hongo Bunkyo-Ku Tokyo

TEL

03-3813-3111

Email

tshukuya@juntendo.ac.jp

Public contact

Name of contact person

1st name Shunichi

Middle name

Last name Kataoka

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Respiratory Medicine

Zip code

113-8421

Address

3-1-3 Hongo Bunkyo-Ku Tokyo

TEL

03-3813-3111

Homepage URL

Email

s-kataoka@juntendo.ac.jp

Sponsor or person

Institute

North East Japan Study Group (NEJSG)

Institute

Department

Personal name

Funding Source

Organization

none

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

Juntendo University Hospital Independent Ethics Committee

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

Tel

03-5802-1584

Email

kenkyu5858@juntendo.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

2025 Year 02 Month 07 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

Enrolling by invitation

Date of protocol fixation

2024 Year 10 Month 11 Day

Date of IRB

2024 Year 12 Month 03 Day

Anticipated trial start date

2024 Year 12 Month 24 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Multicenter Retrospective Observational Study

Management information

Registered date

2025 Year 02 Month 07 Day

Last modified on

2025 Year 02 Month 07 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064993