UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056360 |
|---|---|
| Receipt number | R000064402 |
| Scientific Title | Clinical impact of lymphovascular invasion in pancreatic neuroendocrine tumors: A retrospective multicenter study |
| Date of disclosure of the study information | 2024/12/05 |
| Last modified on | 2024/12/04 22:33:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical impact of lymphovascular invasion in pancreatic neuroendocrine tumors: A retrospective multicenter study
Acronym
Clinical impact of lymphovascular invasion in pancreatic neuroendocrine tumors: A retrospective multicenter study
Scientific Title
Clinical impact of lymphovascular invasion in pancreatic neuroendocrine tumors: A retrospective multicenter study
Scientific Title:Acronym
Clinical impact of lymphovascular invasion in pancreatic neuroendocrine tumors: A retrospective multicenter study
Region
| Japan |
Condition
Condition
The surgically resected pancreatic neuroendocrine tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the impact of lymphovascular invasion on lymph node metastasis and prognosis in pancreatic neuroendocrine tumors
Basic objectives2
Others
Basic objectives -Others
To clarify the clinicopathological characteristics of cases without lymphovascular invasion in pancreatic neuroendocrine tumors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinicopathological characteristics of surgically resected non-functional pancreatic neuroendocrine tumors and insulinomas based on the lymphovascular invasion.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent pancreatic resection and were pathologically diagnosed with pancreatic neuroendocrine tumors between January 1996 and December 2019.
Key exclusion criteria
Surgical resection of recurrence lesions only (e.g., liver metastases, lymph nodes).
Surgical resection of metastatic lesions solely for the purpose of mass reduction or alleviation of hormone-producing symptoms.
Cases in which differentiation from conventional pancreatic cancer is challenging in pathological diagnosis.
Other cases deemed unsuitable for inclusion in this study by the principal investigator or co-investigators.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
shijioka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Yamashige |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
dyamashi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Pancreas Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NCCH
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
irst@ncc.go.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 05 | 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
800
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We aim to investigate recurrence rates, overall survival, progression-free survival by malignancy grade, and recurrence risk factors for each grade of malignancy. Additionally, we plan to create a heatmap for cases without vascular invasion based on the Ki67 labeling index and tumor size.
Management information
Registered date
| 2024 | Year | 12 | Month | 04 | Day |
Last modified on
| 2024 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064402
