UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective, Single-institution Investigation of Opioid use and Survival of patients with advanced or recurrent non-small cell lung cancer.
Acronym	A Prospective, Single-institution Investigation of Opioid use and Survival of patients with advanced or recurrent non-small cell lung cancer.
Scientific Title	A Prospective, Single-institution Investigation of Opioid use and Survival of patients with advanced or recurrent non-small cell lung cancer.
Scientific Title:Acronym	A Prospective, Single-institution Investigation of Opioid use and Survival of patients with advanced or recurrent non-small cell lung cancer.
Region	Japan

Condition
Condition	advanced or recurrent non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine whether survival after diagnosis is associated with opiod dosing and other factors.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	how opioid influenced survival after diagnosis
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	non-small cell lung cancer
Key exclusion criteria	nothing in particular
Target sample size

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hasegawa Takaaki
Organization	Gifu municipal hospital
Division name	Department of respiratory and medical oncology
Zip code
Address	7-1 KASHIMA-CHO GIFU-SHI GIFU
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Gifu municipal hospital
Division name	Department of respiratory and medical oncology
Zip code
Address	7-1 KASHIMA-CHO GIFU-SHI GIFU
TEL
Homepage URL
Email

Sponsor
Institute	Gifu municipal hospital
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2013 Year 04 Month 01 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	Main results already published
Date of protocol fixation	2013 Year 01 Month 30 Day
Date of IRB	2013 Year 01 Month 30 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2016 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	multiple regression analysis to determine the extent to which opioid dosing or other clinical factors (the independent variables:histology, Stage, ECOG PS, Sex) are associated with time till death after diagnosis, prospective study, complete survey in a single institute.

Management information
Registered date	2013 Year 03 Month 29 Day
Last modified on	2019 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011961