UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050295 |
|---|---|
| Receipt number | R000057245 |
| Scientific Title | Prospective observational study examining the impact of sarcopenia in the treatment of advanced stage lung cancer. |
| Date of disclosure of the study information | 2023/02/14 |
| Last modified on | 2023/02/10 11:54:37 |
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Basic information
Public title
Prospective observational study examining the impact of sarcopenia in the treatment of advanced stage lung cancer.
Acronym
sarcopenia research
Scientific Title
Prospective observational study examining the impact of sarcopenia in the treatment of advanced stage lung cancer.
Scientific Title:Acronym
sarcopenia research
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of sarcopenia on the prognosis of patients with advanced stage lung cancer.
(1) Prospective observational study,
(2) Evaluation of muscle mass by bioimpedance method instead of CT or double X-ray absorptiometry,
(3) Analysis of inflammatory cytokines and myokines.
After differentiating from previous reports by the above
We will examine the usefulness of this method as a therapeutic index for sarcopenia and related cytokines.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in progression-free survival with and without sarcopenia
Key secondary outcomes
Difference in overall survival with and without sarcopenia
Difference in response rate by sarcopenia
Adverse events
Analysis of blood samples for inflammatory cytokines and myokines
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases meeting all of the following criteria will be considered eligible .
(1) Patients with pathologically or clinically diagnosed stage III or IV primary lung cancer.
(2) Patients receiving chemotherapy, molecular targeted therapy, immunotherapy, radiation therapy alone or in combination at the hospital.
(3) Patients must be at least 20 years old.
(4) Patients who have received a full explanation of the study and have given their consent.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from the study
(1) Patients who have difficulty undergoing InBody testing.
(2) Patients with psychosis or psychiatric symptoms that make it difficult for them to participate in the study.
(3) Other cases in which the investigator or subinvestigator determines that participation in the study is inappropriate.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
951-8510
Address
1-754 Asahimachidori, Chuouku, Niigata, Japan
TEL
0253689325
satoshi7@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
951-8510
Address
1-754 Asahimachidori, Chuouku, Niigata, Japan
TEL
0253689325
Homepage URL
satoshi7@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata university
Institute
Department
Personal name
Funding Source
Organization
Niigata university
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
Institutional Review Board of the Niigata University
Address
1-757, Asahimachidori, Chuouku, Niigata, Japan
Tel
025-368-9325
joho@med.niigata-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study.
Patients diagnosed with advanced stage lung cancer and treated at our institution between October 1, 2019 and March 31, 2023 were included.
Patients who met the criteria and provided consent were included in the study.
The follow-up period was defined as one year after the last case enrollment.
Management information
Registered date
| 2023 | Year | 02 | Month | 10 | Day |
Last modified on
| 2023 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057245
| Research Plan | |
|---|---|
| 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 |
