UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037186
Receipt number R000042386
Scientific Title Analysis of Correlation between Mass of Muscle/Fat and Tolerability of Chemotherapy in Patients with Advanced Cancer
Date of disclosure of the study information 2019/06/26
Last modified on 2022/12/28 13:46:06

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Basic information

Public title

Analysis of Correlation between Mass of Muscle/Fat and Tolerability of Chemotherapy in Patients with Advanced Cancer

Acronym

Correlation between Mass of Muscle/Fat and Tolerability of Chemotherapy

Scientific Title

Analysis of Correlation between Mass of Muscle/Fat and Tolerability of Chemotherapy in Patients with Advanced Cancer

Scientific Title:Acronym

Correlation between Mass of Muscle/Fat and Tolerability of Chemotherapy

Region

Japan


Condition

Condition

Patients with Advanced Cancer

Classification by specialty

Medicine in general

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation the correlation between mass of muscle/fat and tolerability of chemotherapy

Basic objectives2

Others

Basic objectives -Others

Evaluation the correlation

Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Correlation between
(1)Mass of muscle/fat and their change
and
(2)severe AEs, PS, change of regimen,dose reduction, BSC, prognosis.

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

(1)Advanced cancer
(2)Chemotherapy

Key exclusion criteria

Patients who decline mass of muscle/fat

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Arai

Organization

Chiba University

Division name

Clinical Oncology

Zip code

260-8670

Address

Inohana 1-8-1, Chuo-ku, Chiba City

TEL

043-222-7171

Email

araim-cib@umin.ac.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Arai

Organization

Chiba University

Division name

Clinical Oncology

Zip code

260-8670

Address

Inohana 1-8-1, Chuo-ku, Chiba City

TEL

043-222-7171

Homepage URL


Email

araim-cib@umin.ac.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Chiba University

Address

Inohana 1-8-1, Chuo-ku, Chiba City

Tel

043-222-7171

Email

araim_cib@yahoo.co.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

2019 Year 06 Month 26 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

2019 Year 03 Month 15 Day

Date of IRB

2019 Year 04 Month 23 Day

Anticipated trial start date

2019 Year 06 Month 27 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We evaluate the correlation between the data of mass of muscle/fat and events associated with chemotherapy.


Management information

Registered date

2019 Year 06 Month 26 Day

Last modified on

2022 Year 12 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042386


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name