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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027558
Receipt No. R000031498
Scientific Title Multicenter observational study on the connection between sarcopenia and the curability of chemotherapy in advanced or recurrent colorectal cancer.
Date of disclosure of the study information 2017/05/31
Last modified on 2019/07/12

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Basic information
Public title Multicenter observational study on the connection between sarcopenia and the curability of chemotherapy in advanced or recurrent colorectal cancer.
Acronym Multicenter observational study on the connection between sarcopenia and the curability of chemotherapy in advanced or recurrent colorectal cancer.
Scientific Title Multicenter observational study on the connection between sarcopenia and the curability of chemotherapy in advanced or recurrent colorectal cancer.
Scientific Title:Acronym Multicenter observational study on the connection between sarcopenia and the curability of chemotherapy in advanced or recurrent colorectal cancer.
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim is to investigate the correration of skeletal mass and fat tissue mass calculated by CT with Overall survival, Progression free survival, Response rate, Adverse event rate for the patients registered in KSCC0701, 0801, 0802, 0902, 1002, 1101 who had progressive or reccurent colorectal cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcomes are Overall survival period, relapse free survival period, response rate, Adverse event rate. We are going to investigate the correration the sarcopenia, the rate of skeletal muscle loss and subcutaneous or visceral fat with the primary outcomes.
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. The patient is found to have colorectal cancer histopathologically.
2. The tumor is too progressive or reccurent and no resectable. It is judged by the attending doctor.
3. First line systemic chemotherapy is administered.
4. The patients registered in KSCC0701, 0801, 0802, 0902, 1002, 1101 have the image of CT before the start of chemotherapy and 60 to 120 days or 150 to 210 after chemotherapy.
Key exclusion criteria It is the excluded case that is judged irreverent by the attending doctor.
Target sample size 249

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Oki
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Surgery and Science, Graduate School of Medical Sciences
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL 092-409-3500
Email sanae.sakamoto@ks-cc.or.jp

Public contact
Name of contact person
1st name KSCC
Middle name
Last name Research Secretariat
Organization Kyushu Study group of Clinical Cancer
Division name KSCC Research Secretariat
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL 092-409-3500
Homepage URL
Email sanae.sakamoto@ks-cc.or.jp

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization Kyushu Study group of Clinical Cancer
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyushu University Ethics Review Board
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel 092-641-1151
Email byssien@jimu.kyushu-u.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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 249
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 05 Month 24 Day
Date of IRB
2017 Year 08 Month 02 Day
Anticipated trial start date
2017 Year 05 Month 30 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Skeletal mass area of lower L3 level(m2), Visceral fat area(m2), Subcutaneous fat area(m2), Abdominal circumference(cm), skeletal mass index(SMI=skeletal mass area/Height2), Visceral fat area(VFA)/Subcutaneous fat area(SFA)

Patients' information
Age, Sex, Birth date, Registered number, Body mass index(BMI=Weight/Height2), Labo data(AST, ALT, ALP, Na, K, Alb, Cr, T.Bil, CEA, CA19-9, WBC, Neut, Plt, Hb)

Disease information of the patients'
Clinical stage before treatment, Location of the tumor, History of surgery for the colorectal cancer(Ope date, The histopathological diagnosis), History of the chemotherapy(Regimen, dose, period, Best overall response)

Treatment outcome
Response rate(RR), Progression free survival(PFS), Overall survival(OS), Adverse event rate




Management information
Registered date
2017 Year 05 Month 31 Day
Last modified on
2019 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031498

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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