UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of CD271 expression as a prognostic factor in non-small cell lung cancer patients
Acronym	Evaluation of CD271 expression as a prognostic factor in non-small cell lung cancer patients
Scientific Title	Evaluation of CD271 expression as a prognostic factor in non-small cell lung cancer patients
Scientific Title:Acronym	Evaluation of CD271 expression as a prognostic factor in non-small cell lung cancer patients
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to evaluate the relationship between the expression of CD271, a nerve growth factor receptor, and prognosis in patients with non-small cell lung cancer treated with surgical resection.
Basic objectives2	Others
Basic objectives -Others	We investigate the relationship between the expression of CD271 in non-small cell lung cancer cells and clinicopathological findings.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence-free survival (RFS)
Key secondary outcomes	Overall survival (OS) Association between CD271 staining intensity and clinicopathological findings in non-small cell lung cancer Relationship between the staining intensity of CD271 and the staining intensity of nerve growth factor receptor (NGF, BDGF, Neutrophin) and cancer stromal fibroblast marker molecules (alfa smooth muscle Actin, podoplanin)

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	Non-small cell lung cancer patients who were underwent surgical resection at the Department of Respiratory Surgery, Shiga University of Medical Science Hospital from January 1, 2008 to December 31, 2019
Key exclusion criteria	Patients who have refused to allow their samples and information to be used in this research
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keiko Ueda
Organization	Shiga University of Medical Science
Division name	Department of Thoracic Surgery
Zip code	5202192
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	0775482244
Email	hqsurg2@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Keiko Middle name Ueda Last name Ueda
Organization	Shiga University of Medical Science
Division name	Department of Thoracic Surgery
Zip code	5202192
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	0775482244
Homepage URL
Email	hqsurg2@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
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	Shiga University of Medical Science
Address	Seta Tsukinowa-cho, Otsu, Shiga
Tel	0775482244
Email	hqsurg2@belle.shiga-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 11 Month 10 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	2021 Year 09 Month 15 Day
Date of IRB	2021 Year 09 Month 15 Day
Anticipated trial start date	2021 Year 09 Month 15 Day
Last follow-up date	2028 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	https://rinri.shiga-med.ac.jp/rinri/publish_document.aspx?ID=1539

Management information
Registered date	2021 Year 11 Month 10 Day
Last modified on	2021 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052527