UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044201 |
|---|---|
| Receipt number | 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 | 2022/11/14 16:59:59 |
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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
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
masahiro.goto@ompua.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
2nd Department of Internal Medicine
Institute
Department
Personal name
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
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
132
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
Main results already published
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 12 | Day |
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
| 2022 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050251
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