UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015976 |
|---|---|
| Receipt number | R000018584 |
| Scientific Title | Prospective observational study II on the prognosis of patients with unresectable advanced gastroenteral and pancreatic neuroendocrine tumors in Japan |
| Date of disclosure of the study information | 2014/12/17 |
| Last modified on | 2020/06/26 16:30:55 |
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Basic information
Public title
Prospective observational study II on the prognosis of patients with unresectable advanced gastroenteral and pancreatic neuroendocrine tumors in Japan
Acronym
Prospective observational study II on the prognosis of patients with unresectable advanced gastroenteral and pancreatic neuroendocrine tumors in Japan
Scientific Title
Prospective observational study II on the prognosis of patients with unresectable advanced gastroenteral and pancreatic neuroendocrine tumors in Japan
Scientific Title:Acronym
Prospective observational study II on the prognosis of patients with unresectable advanced gastroenteral and pancreatic neuroendocrine tumors in Japan
Region
| Japan |
Condition
Condition
unresectable advanced gastroenteral and pancreatic neuroendocrine tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate survival outcome and clinical practice in patient with unresectable gastroenteral and pancreatic neuroendocrine tumors (NET) or reccurent one after curative resection diagnosed and to clarify of NET in Japan.
Basic objectives2
Others
Basic objectives -Others
The study on the prognosis of patients with unresectable advanced gastroenteral and pancreatic neuroendocrine tumors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
progression-free survival
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) pathologicaly proven neuroendocrine tumors (NET) as G1/G2, NEC or MANEC
2) unresectable NET or reccurent one after curative resection diagnosed after institutional IRB/IEC approval
3) gastroenteral or pancreatic NET
4) age < 80
5) written informed consent provided from subject (if patients are less than 20 years old, written informed consent provided from their legal representatives is also required)
Key exclusion criteria
1) previously treatment of NET excent for curative resection, neoadjuvant therapy or adjuvant therapy within 1 year before the diagnosis of unresectable NET or reccurent one after curative resection
2) concurrent multiple malignancies
3) resectable reccurent NET after curative resection
4) previously enrolled subject
5) Patients regarded as ineligible for other reason by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ito |
| Middle name | |
| Last name | Tetsuhide |
Organization
Fukuoka Sanno Hospital
Division name
Hepato-Biliary-Pancreatic Medicine and Neuroendocrine tumor Center
Zip code
814-0001
Address
3-6-45, Momochihama, Sawara-ku, Fukuoka City 814-0001 Japan
TEL
092-832-1100
itopapa@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Fujimori |
| Middle name | |
| Last name | Nao |
Organization
Kyushu University Hospital
Division name
Clinical Education Center
Zip code
812-8582
Address
Umade 3-1-1, higashi-ku Hukuoka-shi, Hukuoka 812-5285 Japan
TEL
092-642-5221
Homepage URL
fujimori@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
Foundation for Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KYUSHU UNIVERSITY HOSPITAL Ethics Committee
Address
Umade 3-1-1, higashi-ku Hukuoka-shi, Hukuoka 812-5285 Japan
Tel
092-642-5774
byssien@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
TRINET1326
Org. issuing International ID_1
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 17 | 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
186
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
| 2014 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate survival outcome and clinical practice in patient with unresectable gastroenteral and pancreatic neuroendocrine tumors (NET) or reccurent one after curative resection diagnosed and to clarify of NET in Japan.
Management information
Registered date
| 2014 | Year | 12 | Month | 17 | Day |
Last modified on
| 2020 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018584
