UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of gene alterations in NUT midline carcinoma
Acronym	AMC-NMC-STUDY
Scientific Title	Analysis of gene alterations in NUT midline carcinoma
Scientific Title:Acronym	AMC-NMC-STUDY
Region	Japan

Condition
Condition	Malignant thoracic tumors
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To identify NUT midline carcinoma in malignant thoracic tumors. To identify gene alterations in NUT midline carcinoma.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identifying gene alterations in NUT midline carcinoma
Key secondary outcomes

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 diagnosed with malignant thoracic tumors.
Key exclusion criteria	None
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shunsuke Middle name Last name Okumura
Organization	Asahikawa Medical University Hospital
Division name	Respiratory Center
Zip code	0788510
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL	0166693290
Email	okumura-@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Shunsuke Middle name Last name Okumura
Organization	Asahikawa Medical University Hospital
Division name	Respiratory Center
Zip code	0788510
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL	0166693290
Homepage URL
Email	okumura-@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Asahikawa Medial University Hospital
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
Tel	0166693290
Email	okumura-@asahikawa-med.ac.jp

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	2021 Year 01 Month 27 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	Open public recruiting
Date of protocol fixation	2017 Year 10 Month 25 Day
Date of IRB	2018 Year 03 Month 26 Day
Anticipated trial start date	2018 Year 03 Month 26 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We retrospectively study gene alterations in NUT midline carcinoma.

Management information
Registered date	2021 Year 01 Month 27 Day
Last modified on	2021 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049255