UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029892 |
|---|---|
| Receipt number | R000034073 |
| Scientific Title | The investigation for novel prognostic predictive methods using clinical laboratory test values of patients with cancer |
| Date of disclosure of the study information | 2017/11/09 |
| Last modified on | 2019/11/11 09:50:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The investigation for novel prognostic predictive methods using clinical laboratory test values of patients with cancer
Acronym
The investigation for novel prognostic predictive methods using clinical laboratory test values of patients with cancer
Scientific Title
The investigation for novel prognostic predictive methods using clinical laboratory test values of patients with cancer
Scientific Title:Acronym
The investigation for novel prognostic predictive methods using clinical laboratory test values of patients with cancer
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Predicting life prognosis accurately plays a big role in making meaningful life. There are several prognostic methods currently available, but those can only predict more than three weeks before death, and, the predictive results may be influenced by subjective assessment of medical people. On the other hand, just before death, the lethal complications appear nonspecifically and the whole body condition gets worse, thus, the dynamic changes in clinical laboratory test values may occur. Therefore, in this study, we aim to establish new methods which can objectively predict the short term prognosis using clinical laboratory test values.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, positive predictive value, negative predictive value, area under the ROC curve
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with terminal cancer
Key exclusion criteria
Patients whose survey items are missing, such as no blood test results within one week before and after hospitalization in palliative care units
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Niki |
Organization
Osaka University/Ashiya Municipal Hospital
Division name
Graduate School of Pharmaceutical Sciences/Department of Pharmacy
Zip code
Address
Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1
TEL
06-6879-8250
k-niki@phs.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Niki |
Organization
Osaka University/Ashiya Municipal Hospital
Division name
Graduate School of Pharmaceutical Sciences/Department of Pharmacy
Zip code
Address
Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1
TEL
06-6879-8250
Homepage URL
k-niki@phs.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
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
Address
Tel
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
| 2017 | Year | 11 | Month | 09 | 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
| 2017 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Background information of subjects
Management information
Registered date
| 2017 | Year | 11 | Month | 09 | Day |
Last modified on
| 2019 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034073
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
