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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000037451 |
Receipt No. | R000042646 |
Scientific Title | Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events |
Date of disclosure of the study information | 2019/07/29 |
Last modified on | 2019/08/29 |
Basic information | ||
Public title | Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events | |
Acronym | Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events | |
Scientific Title | Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events | |
Scientific Title:Acronym | Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events | |
Region |
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Condition | ||
Condition | Lung Cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the association between values of BIA, clinical backgrounds, efficiencies of treatment, and adverse events in lung cancer patients before treatment.
*Values of BIA are Body Mass Index (BMI), Soft Lean Mass(SLM), Fat Free Mass Index(FFMI), Skeletal Muscle Mass Index(SMI), phase angle(Ph A), ratio of extracellular water to total body water(ECW/TBW), ratio of extracellular water to intracellular water(ECW/ICW). **Clinical backgrounds are age, sex, Performance Status(PS), smoking history, histologic feature, clinical stage, sites of metastases and previous systemic therapies. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Association between ECW/TBW in BIA and efficiencies or adverse events of anti-cancer treatment |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Patient who received ICI plus chemotherapyor platinum doublet alone as first-line regimen
2. Patient with recurrence lung cancer or unresectable progression caner 3.Diagnosis of small cell lung cancer or the non-small-cell lung cancer 4.Patient was 20 years oldor morehe at registration 5. Patient with Performance Status 0-2 5. Patient with the evaluable lesion 6. Written informed consent was obtained from the patient |
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Key exclusion criteria | Patient with a pacemaker | |||
Target sample size | 55 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka Prefectual Hospital Organization
Osaka Habikino Medical Center |
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Division name | Thoracic Oncology | ||||||
Zip code | 583-8588 | ||||||
Address | 3-7-1,Habikino,Habikino-City,Osaka | ||||||
TEL | 0729572121 | ||||||
hirashimat@ra.opho.jp |
Public contact | |||||||
Name of contact person |
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Organization | Osaka Prefectual Hospital Organization, Osaka Habikino Medical Center | ||||||
Division name | Thoracic Oncology | ||||||
Zip code | 583-8588 | ||||||
Address | 3-7-1,Habikino,Habikino-City,Osaka | ||||||
TEL | 0729572121 | ||||||
Homepage URL | |||||||
hirashimat@ra.opho.jp |
Sponsor | |
Institute | Osaka Prefectual Hospital Organization
Osaka Habikino Medical Center |
Institute | |
Department |
Funding Source | |
Organization | Osaka Prefectual Hospital Organization
Osaka Habikino Medical Center |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Osaka Prefectual Hospital Organization, Osaka Habikino Medical Center |
Address | 3-7-1,Habikino,Habikino-City,Osaka |
Tel | 0729572121 |
takatsur@opho.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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Recruitment status | Open public recruiting | ||||||
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Other | |
Other related information | nothing |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042646 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |