UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027558 |
|---|---|
| Receipt number | 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 11:08:29 |
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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
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
sanae.sakamoto@ks-cc.or.jp
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031498
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
