UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005804 |
|---|---|
| Receipt number | R000006843 |
| Scientific Title | The predictive value of measuring immature platelet fraction (IPF) in the recovery from thrombocytopenia caused by chemotherapy in lung cancer patients |
| Date of disclosure of the study information | 2011/06/22 |
| Last modified on | 2019/02/16 15:40:32 |
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Basic information
Public title
The predictive value of measuring immature platelet fraction (IPF) in the recovery from thrombocytopenia caused by chemotherapy in lung cancer patients
Acronym
The predictive value of immature platelet fraction (IPF) in the recovery from thrombocytopenia in lung cancer chemotherapy
Scientific Title
The predictive value of measuring immature platelet fraction (IPF) in the recovery from thrombocytopenia caused by chemotherapy in lung cancer patients
Scientific Title:Acronym
The predictive value of immature platelet fraction (IPF) in the recovery from thrombocytopenia in lung cancer chemotherapy
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the usefulness of measuring immmature platelet fraction as the predictive factor for the recovery from thronbocytopenia in lung cancer chemotherapy
Basic objectives2
Others
Basic objectives -Others
the acuracy of predicting to recover from thrombocytopenia
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
recovery from thronbocytopenia
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
lung cancer patients recieved chemotherapy
Key exclusion criteria
lung cancer patients not recieved chemotherapy
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeaki Ogura |
Organization
Hokkaido Medical Center, Natinal Hospital Organaizetion
Division name
Department of Respirology
Zip code
Address
Yamanote 5-jo 7-chome, Nishi-ku, Sapporo, Hokkaido
TEL
011-611-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeaki Ogura |
Organization
Hokkaido Medical Center
Division name
Department of Respirology
Zip code
Address
Yamanote 5-jo 7-chome, Nishi-ku, Sapporo, Hokkaido
TEL
011-611-8111
Homepage URL
Sponsor or person
Institute
Hokkaido Medical Center, Natinal Hospital Organaizetion
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Medical Center, Natinal Hospital Organaizetion
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Asahikawa Medical Center, Natinal Hospital Organaizetion
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
北海道医療センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
twice a week, platelet and IPF are measured at least during chemotherapy.
If Grade 3 thrombocytopenia occures, platelet and IPF are measured every two days until the recovery.
Management information
Registered date
| 2011 | Year | 06 | Month | 19 | Day |
Last modified on
| 2019 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006843
