UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037451
Receipt number R000042646
Scientific Title Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events
Date of disclosure of the study information 2019/07/29
Last modified on 2022/02/04 14:52:54

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Basic information

Public title

Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events

Acronym

Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events

Scientific Title

Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events

Scientific Title:Acronym

Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events

Region

Japan


Condition

Condition

Lung Cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the association between values of BIA, clinical backgrounds, efficiencies of treatment, and adverse events in lung cancer patients before treatment.
*Values of BIA are Body Mass Index (BMI), Soft Lean Mass(SLM), Fat Free Mass Index(FFMI), Skeletal Muscle Mass Index(SMI), phase angle(Ph A), ratio of extracellular water to total body water(ECW/TBW), ratio of extracellular water to intracellular water(ECW/ICW).
**Clinical backgrounds are age, sex, Performance Status(PS), smoking history, histologic feature, clinical stage, sites of metastases and previous systemic therapies.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Association between ECW/TBW in BIA and efficiencies or adverse events of anti-cancer treatment

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.Patient who received ICI plus chemotherapyor platinum doublet alone as first-line regimen
2. Patient with recurrence lung cancer or unresectable progression caner
3.Diagnosis of small cell lung cancer or the non-small-cell lung cancer
4.Patient was 20 years oldor morehe at registration
5. Patient with Performance Status 0-2
5. Patient with the evaluable lesion
6. Written informed consent was obtained from the patient

Key exclusion criteria

Patient with a pacemaker

Target sample size

55


Research contact person

Name of lead principal investigator

1st name Tomonori
Middle name
Last name Hirashima

Organization

Osaka Prefectual Hospital Organization
Osaka Habikino Medical Center

Division name

Thoracic Oncology

Zip code

583-8588

Address

3-7-1,Habikino,Habikino-City,Osaka

TEL

0729572121

Email

hirashimat@ra.opho.jp


Public contact

Name of contact person

1st name Tomonori
Middle name
Last name Hirashima

Organization

Osaka Prefectual Hospital Organization, Osaka Habikino Medical Center

Division name

Thoracic Oncology

Zip code

583-8588

Address

3-7-1,Habikino,Habikino-City,Osaka

TEL

0729572121

Homepage URL


Email

hirashimat@ra.opho.jp


Sponsor or person

Institute

Osaka Prefectual Hospital Organization
Osaka Habikino Medical Center

Institute

Department

Personal name



Funding Source

Organization

Osaka Prefectual Hospital Organization
Osaka Habikino Medical Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Hospital Organization Kinki-Chuo Chest Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka Prefectual Hospital Organization, Osaka Habikino Medical Center

Address

3-7-1,Habikino,Habikino-City,Osaka

Tel

0729572121

Email

nishibayashih@opho.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

地方独立行政法人大阪府立病院機構大阪はびきの医療センター(大阪府)、独立行政法人国立病院機構 近畿中央呼吸器センター(大阪府)


Other administrative information

Date of disclosure of the study information

2019 Year 07 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

No longer recruiting

Date of protocol fixation

2019 Year 04 Month 15 Day

Date of IRB

2019 Year 05 Month 31 Day

Anticipated trial start date

2019 Year 07 Month 29 Day

Last follow-up date

2022 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

nothing


Management information

Registered date

2019 Year 07 Month 22 Day

Last modified on

2022 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042646


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name