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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000008892
Receipt No. R000010432
Scientific Title Japan Prognostic measurement tools Validation Study: J-ProVal study
Date of disclosure of the study information 2012/09/11
Last modified on 2016/09/15

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Basic information
Public title Japan Prognostic measurement tools Validation Study: J-ProVal study
Acronym J-ProVal study
Scientific Title Japan Prognostic measurement tools Validation Study: J-ProVal study
Scientific Title:Acronym J-ProVal study
Region
Japan

Condition
Condition Advanced cancer
Classification by specialty
Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the predictive accuracy of the Palliative Prognostic Score: PaP score, Palliative Prognostic Index: PPI, and Prognosis in Palliative care Study predictor models: PiPS models.
Basic objectives2 Others
Basic objectives -Others Predictive values
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Survival
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Adult
2 Cancer patients with locally advanced or metastasis
3) Receiving specialized pallaitive care services
Key exclusion criteria None
Target sample size 2150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mika Baba
Organization Saito Yukoukai Hospital
Division name Pallaitive Medicine
Zip code
Address 7-2-18 Saitoasagi, Ibaragi
TEL 0726416898
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mika Baba
Organization Saito Yukoukai Hospital
Division name Pallaitive Medicine
Zip code
Address 7-2-18 Saitoasagi, Ibaragi
TEL 0726416898
Homepage URL
Email mmika@s9.dion.ne.jp

Sponsor
Institute Saito Yukoukai Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Lavor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 彩都友紘会病院
手稲渓仁会病院
旭川医科大学病院
弘前大学医学部附属病院
山形大学医学部付属病院
三井記念病院
帝京大学医学部
日本医科大学附属病院
横浜市立市民病院
筑波大学附属病院
亀田総合病院
静岡済生会総合病院
聖隷浜松病院
聖隷三方原病院
名古屋医療センター
済生会松阪総合病院
和歌山県立医科大学附属病院
大阪府立成人病センター
大阪医療センター
近畿中央胸部疾患センター
三菱京都病院
松江市立病院
福山市民病院
九州がんセンター
社会医療法人友愛会 南部病院
東札幌病院
東北大学病院
聖路加国際病院
都立駒込病院
東芝病院
東京厚生年金病院
つくばセントラル病院
筑波メディカルセンター病院
国立がん研究センター東病院
施設
新生病院
静岡県立静岡がんセンター
聖隷三方原病院
小牧市民病院
名古屋掖済会病院
藤田保健衛生大学 七栗サナトリウム
淀川キリスト教病院
大阪市立総合医療センター
ガラシア病院
社会保険神戸中央病院
岡山済生会総合病院
藤井政雄記念病院
緩和クリニック・恵庭
KKR札幌医療センター
いまいホームケアクリニック
仙台往診クリニック
岡部医院 
ふくしま在宅緩和ケアクリニック
要町病院 要町ホームケアクリニック
湘南国際村クリニック
めぐみ在宅クリニック
川崎市立井田病院かわさき総合ケアセンター
ピースクリニック中井
大和クリニック
あおぞら診療所
宍戸内科医院
ひだまり診療所
佐久総合病院
坂の上ファミリークリニック
すぎもと在宅医療クリニック
大阪北ホームケアクリニック
千里ペインクリニック
医療法人出水クリニック
関本クリニック
ホームケアクリニックこうべ
施設
しんじょう医院
ひまわり在宅クリニック

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 11 Day

Related information
URL releasing protocol
Publication of results 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 Main results already published
Date of protocol fixation
2012 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 18 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
2014 Year 05 Month 31 Day
Date trial data considered complete
2014 Year 08 Month 07 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information under sub group analysis

Management information
Registered date
2012 Year 09 Month 11 Day
Last modified on
2016 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010432

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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