UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011968
Receipt number R000012505
Scientific Title Ion mobility spectrometry measurements before and after treatment of lung cancer
Date of disclosure of the study information 2013/10/06
Last modified on 2013/10/06 10:36:27

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Basic information

Public title

Ion mobility spectrometry measurements before and after treatment of lung cancer

Acronym

IMS before and after treatment of lung cancer

Scientific Title

Ion mobility spectrometry measurements before and after treatment of lung cancer

Scientific Title:Acronym

IMS before and after treatment of lung cancer

Region

Japan


Condition

Condition

Patients that will undergo lung cancer surgery, chemotherapy, radiation therapy and chemoradiation therapy

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess VOC levels in exhaled breath before and after treatment in patients with lung cancer.
Identification of VOC peaks for specific lung cancers.
Identification of treatment outcomes.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To observe if VOC peaks specific to lung cancer show changes after treatment.

Key secondary outcomes

To evaluate VOC peak changes for different treatments; chemotherapy, radiation therapy and chemoradiation therapy.
To measure VOC peaks for the affected and healthy side of the lungs during single-sided ventilation.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Lung cancer:
To collect 10ml of exhaled air using BioScout.

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) patients 20 years of age or over with lung cancer.
2) Agree to give informed consent

Key exclusion criteria

1) Refuse to give informed consent
2) Patients who are pregnant, possibly pregnant, or lactating.
3) Patients with renal failure. (serum creatinine > 2.0 mg/dL, BUN > 30mg/dl)
4) AST or ALT > 100IU
5) Patients with severe diabetes, hyperlipidemia or hyperuricemia
6) Patients who are judged inappropriate by the doctor in charge.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Teruomi Miyazawa

Organization

St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of Internal Medicine

Division name

Division of Respiratory and Infectious Diseases, Department of Internal Medicine

Zip code


Address

2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511

TEL

044-977-8111

Email

m2okamoto@marianna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mariko Okamoto

Organization

St. Marianna University School of Medicine

Division name

Division of Respiratory and Infectious Diseases, Department of Internal Medicine

Zip code


Address

2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511

TEL

044-977-8111

Homepage URL


Email

m2okamoto@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of Internal Medicine

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 10 Month 06 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

2013 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 06 Day

Last modified on

2013 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012505


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name