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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019087
Receipt No. R000021878
Scientific Title Secondary tumors of the pancreas, a multicenter retrospective study
Date of disclosure of the study information 2015/11/01
Last modified on 2019/03/25

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Basic information
Public title Secondary tumors of the pancreas, a multicenter retrospective study
Acronym Secondary tumors of the pancreas, a multicenter retrospective study (STEP study)
Scientific Title Secondary tumors of the pancreas, a multicenter retrospective study
Scientific Title:Acronym Secondary tumors of the pancreas, a multicenter retrospective study (STEP study)
Region
Japan

Condition
Condition Secondary tumors of the pancreas
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the primary tumor sites
Basic objectives2 Others
Basic objectives -Others To clarify the methods of histological diagnosis, treatment, and prognosis of each primary tumor site.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To clarify the percentage of primary tumor sites
Key secondary outcomes Tumor information (number, size, site etc), the method of histological diagnosis, the treatment, and the prognosis.

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
10 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria histopathologically confirmed
Key exclusion criteria Primary pancreatic tumors.
Direct invasion to the pancreas from cancers of sorrounding other organs.
Autopsy cases.
The inappropriate cases.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Shujiro
Middle name
Last name Yazumi
Organization Kitano Hospital, The Tazuke Kofukai, Medical Reserch Institute
Division name Digestive Disease Center
Zip code 530-8480
Address 2-4-20, Ohgimachi, Kita-ku, Osaka-shi, Osaka, 530-8480, Japan
TEL 06-6312-1221
Email s-yazumi@kitano-hp.or.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Ito
Organization Kitano Hospital, The Tazuke Kofukai, Medical Reserch Institute
Division name Digestive Disease Center
Zip code 5308480
Address 2-4-20, Ohgimachi, Kita-ku, Osaka-shi, Osaka, 530-8480, Japan
TEL 06-6312-1221
Homepage URL
Email kmus0416@yahoo.co.jp

Sponsor
Institute Bilio-pancreatic Stenting Study Group
Institute
Department

Funding Source
Organization Bilio-pancreatic Stenting Study Group
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 IRB in Kitano Hospital
Address 2-4-20, Ohgimachi, Kita-ku, Osaka-shi, Osaka, 530-8480, Japan
Tel 06-6312-1221
Email rinshou@kitano-hp.or.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 Bilio-pancreatic Stenting 研究会に所属している病院群(大阪府など西日本の基幹病院)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 01 Day

Related information
URL releasing protocol https://journals.lww.com/pancreasjournal/fulltext/2018/09000/Analysis_of_Prognostic_Factors_in_Pancr
Publication of results Unpublished

Result
URL related to results and publications https://journals.lww.com/pancreasjournal/fulltext/2018/09000/Analysis_of_Prognostic_Factors_in_Pancr
Number of participants that the trial has enrolled 159
Results We enrolled 159 patients with a pathologic diagnosis of PM. The most common primary tumor was renal cell carcinoma (38.4%), followed by lung cancer (24.5%), colorectal cancer (11.3%), and sarcoma (6.3%). Median overall survival was 43 months, and the 5-year survival rate was 42.6%. Multivariate analysis identified 3 independent prognostic factors: extrapancreatic metastasis (P = 0.02), tumor-related symptoms at diagnosis (P < 0.001), and pathologic diagnosis of primary tumors (P < 0.001).
Results date posted
2019 Year 03 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The study included 95 men and 64 wemen witha amedian age of 74.5 years. The most common primary tumors was RCC (38.4%), followed by lung cancer (24.5%), colorectal cancer (11.3%), sarcoma (6.3%), and breast cancer (6.3%).
Participant flow Of the 174 patients identified by each institutional database as having a diagnosis of PMs, 159 patients were included in the study. Reasons for exclusion were tumor of pancreatic origin (gastrointestinal stromal tumor; n = 2), malignant lymphoma (n = 2), not pathologically confirmed (n = 9), autopsy case (n = 1), and insufficient information (n = 1).
Adverse events none
Outcome measures We enrolled 159 patients with a pathologic diagnosis of PM. The most common primary tumor was renal cell carcinoma (38.4%), followed by lung cancer (24.5%), colorectal cancer (11.3%), and sarcoma (6.3%). Median overall survival was 43 months, and the 5-year survival rate was 42.6%. Multivariate analysis identified 3 independent prognostic factors: extrapancreatic metastasis (P = 0.02), tumor-related symptoms at diagnosis (P < 0.001), and pathologic diagnosis of primary tumors (P < 0.001).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 09 Month 30 Day
Date of IRB
2015 Year 10 Month 30 Day
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
2016 Year 08 Month 31 Day
Date of closure to data entry
2016 Year 08 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information From January 2005 to August 2015, the patients, in whom secondary tumors of the pancreas were histopathologically confirmed, were enrolled

Management information
Registered date
2015 Year 09 Month 21 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021878

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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