UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032917 |
|---|---|
| Receipt number | 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 13:49:06 |
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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
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
atmasuda@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037307
