UMIN-CTR Clinical Trial

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
Email	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
Email	fujimori@intmed3.med.kyushu-u.ac.jp

Sponsor
Institute	Foundation for Biomedical Research and Innovation
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018584