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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032917
Receipt No. R000037307
Scientific Title Observational study on gene mutation and prognosis for patients with resectable pancreatic cancer
Date of disclosure of the study information 2018/07/01
Last modified on 2020/09/18

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Basic information
Public title




Observational study on gene mutation and prognosis for patients with resectable pancreatic cancer
Acronym




Observational study on gene mutation and prognosis for patients with resectable pancreatic cancer
Scientific Title




Observational study on gene mutation and prognosis for patients with resectable pancreatic cancer
Scientific Title:Acronym




Observational study on gene mutation and prognosis for patients with resectable pancreatic cancer
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Relationship between genetic alteration and prognosis in pancreatic cancer
Basic objectives2 Others
Basic objectives -Others Search for factors related to gene mutation and prognosis of pancreatic cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between gene mutation (KRAS, TP53, CDKN2A, SMAD4) and prognosis in patients with surgically treated pancreatic cancer
Key secondary outcomes The relationship between the following items and the relation between gene mutation or prognosis in pancreatic cancer patients who underwent surgical treatment
1)presence or absence of IPMN coexistence
2)desmoplastic change
3)diabetic status
4)smoking history
5)local immune responses(TIL:Tumor Infiltrating Lymphocyte, TLS:Tertiary Lymphoid Structure )
6)systemic immune responses(ALC:Absolute Lymphocyte Counts, ANC:Absolute Neutrophil Counts, NLR:Neutrophil-to-Lymphocyte Ratio)

The relationship between desmoplastic change and preoperative image findings

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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patient who can obtain medical treatment content from medical record
Patients who underwent surgical treatment for pancreatic cancer at Kobe university hospital between January 2008 and May 2017
Key exclusion criteria Patients who did not participate in this research from published information
Patients under 20 years of age
Target sample size 219

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Masuda
Organization Kobe University Graduate School of Medicine
Division name Gastroenterology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL 078-382-6305
Email atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuhiro Masuda
Organization Kobe University Graduate School of Medicine
Division name Gastroenterology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL 078-382-6305
Homepage URL
Email atmasuda@med.kobe-u.ac.jp

Sponsor
Institute Kobe university
Institute
Department

Funding Source
Organization self funding
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 25 Day
Date of IRB
2018 Year 06 Month 15 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We perform DNA analysis using specimens after resection of pancreatic cancer and retrospectively examine prognosis, patient background, blood examination data, imaging findings, treatments.

Management information
Registered date
2018 Year 06 Month 08 Day
Last modified on
2020 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037307

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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