UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Galectin-3 expression as a prognostic factor in non-small cell lung cancer patients
Title of the study (Brief title)	Evaluation of Galectin-3 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 is to evaluate Galectin-3 expression as a prognostic factor in patients with surgically resected non-small cell lung cancer.
Basic objectives2	Others
Basic objectives -Others	We examine the correlation between Galectin-3 expression in non-small cell lung cancer and clinicopahtological features.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence-free survival (RFS)
Key secondary outcomes	1) Overall survival (OS) 2) To evaluate the correlation between Galectin-3 expression in non-small cell lung cancer tissues and clinicopathological features 3) To investigate the correlation between Galectin-3 expression in tissue and serum from non-small cell lung cancer patients

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 underwent surgical resection in Shiga University of Medical Science Hospital between January 2007 and December 2015.
Key exclusion criteria	Not applicable
Target sample size	250

Research contact person
Name of lead principal investigator	Yoko Kataoka
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Address	Seta-Tsukinowa, Otsu, Shiga
TEL	077-548-2244
Email	hqsurg2@belle.shiga-med.ac.jp

Public contact
Name of contact person	Yoko Kataoka
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Address	Seta-Tsukinowa, Otsu, Shiga
TEL	077-548-2244
Homepage URL
Email	hqsurg2@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

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)

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 05 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To evaluate Galectin-3 expression as a prognostic factor in patients with surgically resected non-small cell lung cancer.

Management information
Registered date	2017 Year 04 Month 05 Day
Last modified on	2017 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030832