UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019087 |
|---|---|
| Receipt number | 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 20:24:33 |
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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
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
kmus0416@yahoo.co.jp
Sponsor or person
Institute
Bilio-pancreatic Stenting Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021878
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