UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030176
Receipt number R000034466
Scientific Title Efficacy of 5-HTTLPR on post thoracotomy pain syndrome after lung surgery for cancer: prospective observational study.
Date of disclosure of the study information 2017/11/29
Last modified on 2020/06/01 18:42:25

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Basic information

Public title

Efficacy of 5-HTTLPR on post thoracotomy pain syndrome after lung surgery for cancer: prospective observational study.

Acronym

Efficacy of 5-HTTLPR on post thoracotomy pain syndrome after lung surgery.

Scientific Title

Efficacy of 5-HTTLPR on post thoracotomy pain syndrome after lung surgery for cancer: prospective observational study.

Scientific Title:Acronym

Efficacy of 5-HTTLPR on post thoracotomy pain syndrome after lung surgery.

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To investigate the correlation between 5-HTTLPR polymorphisms and post thoracotomy pain syndrome after lung cancer surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pain scale of surgical site (numeric rating scale, 6 months after surgery)

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

adult patients who are scheduled to undergo lung surgery for cancer

Key exclusion criteria

patients with mental disorder, congnitive disoeder, ASA physical status classification5 or 6

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Yamasaki

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

5458586

Address

1-5-7 Asahi-machi Abeno-ku Osaka

TEL

06-6645-2186

Email

joudannz@yahoo.co.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Yamasaki

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

5458586

Address

1-5-7 Asahi-machi Abeno-ku Osaka

TEL

06-6645-2186

Homepage URL


Email

joudannz@yahoo.co.jp


Sponsor or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

Ethical Committee of Osaka City University Graduate School of Medicine

Address

1-5-7 Asahi-machi Abeno-ku Osaka

Tel

0666453456

Email

ethics@med.osaka-cu.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

2017 Year 11 Month 29 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

Completed

Date of protocol fixation

2017 Year 09 Month 30 Day

Date of IRB

2017 Year 08 Month 03 Day

Anticipated trial start date

2017 Year 11 Month 29 Day

Last follow-up date

2019 Year 10 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2017 Year 11 Month 29 Day

Last modified on

2020 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034466


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name