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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044201
Receipt No. R000050251
Scientific Title Relation with prognosis and sarcopenia in patients undergoing systemic chemotherapy for advanced gastric cancer; retrospective study
Date of disclosure of the study information 2021/06/30
Last modified on 2021/05/13

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Basic information
Public title Relation with prognosis and sarcopenia in patients undergoing systemic chemotherapy for advanced gastric cancer; retrospective study
Acronym Relation with prognosis and sarcopenia in patients undergoing systemic chemotherapy for advanced gastric cancer; retrospective study
Scientific Title Relation with prognosis and sarcopenia in patients undergoing systemic chemotherapy for advanced gastric cancer; retrospective study
Scientific Title:Acronym Relation with prognosis and sarcopenia in patients undergoing systemic chemotherapy for advanced gastric cancer; retrospective study
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 By measuring intramuscular adipose tissue content (IMAC) in addition to body mass index and iliopsoas muscle mass ,we will investigate the relationship between sarcopenia and life prognosis retrospectively.
Basic objectives2 Others
Basic objectives -Others Examination of the relationship between general condition and prognosis before chemotherapy
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between intramuscular adipose tissue content (IMAC) and overall survival
Key secondary outcomes ・ody Mass Index before chemotherapy.
・CONUTscore
・Correlation between iliopsoas muscle mass and overall survival
・Differences between chemotherapy regimens

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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Endoscopic biopsy from the primary leision has confirmed histologically adenocarcinoma (one of the general types of histological classification). In addition, HER2 status does not matter.
2)Patients who received chemotherapy for advanced gastric cancer at our hospital between April 2016 and March 2021.However, it does not matter whether metastasis, recurrence or primary lesion is resected.
3There are no serious complications affecting chemotherapy or surgery at diagnosis.
Key exclusion criteria no Exclusion criteria
Target sample size 164

Research contact person
Name of lead principal investigator
1st name Kazuhide
Middle name
Last name Higuchi
Organization Osaka Medical and Pharmaceutical University
Division name 2nd Department of Internal Medicine
Zip code 569-8686
Address 2-7 Daigakumachi, Takasuki, Osaka, Japan
TEL 072-683-1221
Email kazuhide.higuchi@ompu.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Gotoh
Organization Osaka Medical and Pharmaceutical University
Division name Cancer Chemotherapy Center
Zip code 569-8686
Address 2-7 Daigakumachi, Takatsuki, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email masahiro.goto@ompua.ac.jp

Sponsor
Institute Osaka Medical and Pharmaceutical University
2nd Department of Internal Medicine
Institute
Department

Funding Source
Organization Osaka Medical and Pharmaceutical University
2nd 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 Osaka Medical and Pharmaceutical University
Address 2-7 Daigakumachi, Takatsuki, Osaka, Japan
Tel 072-683-1221
Email rinri@ompu.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

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 30 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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patient's information is obtained from the patient's chart.
The contents to be obtained from the chart are as fellows.

Patient background: age, gender, performance status, height, weight, BMI
Laboratory findings before chemotherapy: CT, blood test, pathological test, HER2 status
Vincent is used to analyze CT findings.
Treatment course: surgery, chemotherapy regimen, imaging findings, adverse events, recurrence confirmation date
Outcome: date of death, date of final confirmation of survival, reason for death; primary disease or other diseases or unknown



Management information
Registered date
2021 Year 05 Month 13 Day
Last modified on
2021 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050251

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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