UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056506 |
|---|---|
| Receipt number | R000064575 |
| Scientific Title | A multicenter retrospective study on the frequency of recurrence and risk factors for recurrence following surgical resection of pancreatic neuroendocrine tumors. |
| Date of disclosure of the study information | 2024/12/20 |
| Last modified on | 2024/12/19 21:26:41 |
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Basic information
Public title
A multicenter retrospective study on the frequency of recurrence and risk factors for recurrence following surgical resection of pancreatic neuroendocrine tumors.
Acronym
A retrospective study on the frequency and risk factors of recurrence following surgical resection of pancreatic neuroendocrine tumors.
Scientific Title
A multicenter retrospective study on the frequency of recurrence and risk factors for recurrence following surgical resection of pancreatic neuroendocrine tumors.
Scientific Title:Acronym
A retrospective study on the frequency and risk factors of recurrence following surgical resection of pancreatic neuroendocrine tumors.
Region
| Japan |
Condition
Condition
The surgically resected pancreatic neuroendocrine tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the frequency of recurrence following surgical resection.
Basic objectives2
Others
Basic objectives -Others
To identify risk factors for recurrence following surgical resection.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of risk factors for recurrence in all surgically resected pancreatic neuroendocrine tumors.
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 meet all of the following criteria at the time of registration are included:
1. Patients who underwent pancreatic resection between January 1996 and December 2019 and were pathologically diagnosed with pancreatic neuroendocrine tumors (including NEC G3 and MiNEN), regardless of the surgical procedure.
2. Immunohistochemical staining for Ki67 was performed on resected specimens, and the Ki67 labeling index is available.
3. Malignancy grading based on the WHO 2019 classification (NET G1, G2, G3, NEC G3, MiNEN) is feasible.
Key exclusion criteria
1. Surgical resection of recurrence lesions only (e.g., liver metastases, lymph nodes).
2. Surgical resection of metastatic lesions solely for the purpose of mass reduction or alleviation of hormone-producing symptoms.
3. Cases in which differentiation from conventional pancreatic cancer is challenging in pathological diagnosis.
4. 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 | Yasuhiro |
| Middle name | |
| Last name | Komori |
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
yakomor@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 | 20 | 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
Observation and Examination Items
1. Patient characteristics: Gender, age at the time of surgery.
2. Presence of hormonal symptoms: Presence or absence of functional NET.
3. Hereditary tumors: Presence or absence of hereditary tumors (e.g., MEN1, VHL).
4. Tumor characteristics: Tumor location, size, and imaging findings.
5. Clinical stage: Classification of the clinical stage.
6. Preoperative treatment: Presence and type of any preoperative treatment.
7. Surgical details: Date of surgery and surgical procedures performed.
8. Postoperative complications: Presence or absence of surgery-related mortality, frequency of pancreatic fistula, and frequency of severe complications.
9. Pathological diagnosis: Detailed pathological findings of pancreatic NET, including staging and vascular invasion based on the General Rules for the Study of Pancreatic Cancer.
10. Adjuvant therapy: Presence or absence of postoperative adjuvant therapy.
11. Time to adjuvant therapy: Interval from surgery to the initiation of postoperative adjuvant therapy.
12. Details of adjuvant therapy: Content of postoperative adjuvant therapy.
13. Duration of adjuvant therapy: Duration of postoperative adjuvant therapy.
14. Recurrence: Presence or absence of recurrence.
15. Recurrence patterns: Types of recurrence.
16. Overall survival (OS): Total survival period.
17. Recurrence-free survival (RFS): Duration of survival without recurrence.
Management information
Registered date
| 2024 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064575
