UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028135
Receipt number R000032200
Scientific Title Role of microbiome and clock gene in pulmonary resection for the patients with lung tumor
Date of disclosure of the study information 2017/07/07
Last modified on 2017/07/07 18:26:55

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Basic information

Public title

Role of microbiome and clock gene in pulmonary resection for the patients with lung tumor

Acronym

Microbiome for the patients with lung tumor

Scientific Title

Role of microbiome and clock gene in pulmonary resection for the patients with lung tumor

Scientific Title:Acronym

Microbiome for the patients with lung tumor

Region

Japan


Condition

Condition

Lung tumors

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the role of microbiome, inflammatory cytokines, and clock gene in patients undergoing pulmonary resection surgery

Basic objectives2

Others

Basic objectives -Others

To evaluate the role of microbiome, inflammatory cytokines, and clock gene in patients undergoing pulmonary resection surgery

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Expression analyses of microbiome, inflammatory cytokines, and clock gene in the patients with lung tumors

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

1. Scheduled to receive pulmonary resection surgery.
2. Patients must be aged 20 years or older.
3. Written informed consent is provided by the patient.

Key exclusion criteria

None

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukiyasu Takeuchi

Organization

National Hospital Organization Toneyama Hospital

Division name

General Thoracic Surgery

Zip code


Address

5-1-1 Toneyama, Toyonaka-City, Osaka

TEL

0668532001

Email

ytakeuch@toneyama.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akio Hayashi

Organization

National Hospital Organization Toneyama Hospital

Division name

General Thoracic Surgery

Zip code


Address

5-1-1 Toneyama, Toyonaka-City, Osaka

TEL

0668532001

Homepage URL


Email

ahayashi@toneyama.go.jp


Sponsor or person

Institute

Department of General Thoracic Surgery, National Hospital Organization Toneyama Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of General Thoracic Surgery, National Hospital Organization Toneyama Hospital

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

国立病院機構刀根山病院(大阪府)


Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 07 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 07 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 07 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 09 Month 30 Day

Date analysis concluded

2019 Year 12 Month 31 Day


Other

Other related information

None


Management information

Registered date

2017 Year 07 Month 07 Day

Last modified on

2017 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032200


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name