UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025215 |
|---|---|
| Receipt number | R000029004 |
| Scientific Title | Multicenter prospective study of colorectal neuroendocrine tumors |
| Date of disclosure of the study information | 2016/12/10 |
| Last modified on | 2020/06/19 10:58:42 |
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Basic information
Public title
Multicenter prospective study of colorectal neuroendocrine tumors
Acronym
C-NET STUDY
Scientific Title
Multicenter prospective study of colorectal neuroendocrine tumors
Scientific Title:Acronym
C-NET STUDY
Region
| Japan |
Condition
Condition
Colorectal neuroendocrine tumor (NET)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the clinicopathological characteristics, diagnosis, treatment, clinical outocomes (recurrence/ metastasis), and prognosis of colorectal neuroendocrine tumors (NETs).
Basic objectives2
Others
Basic objectives -Others
To collect and follow data of colorectal neuroendocrine tumors (NETs) from multiple centers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence and metastasis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Colonoscopy and abdominal computed tomography 1, 5 and 10 years after registration
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged between 20 and 74 years with pathologically confirmed colorectal neuroendocrine tumors
Key exclusion criteria
1. Cases in which it is difficult to get informed consent
2. Cases which are considered as inappropriate by doctors
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Matsuda |
Organization
National Cancer Center Hospital
Division name
Cancer Screening Center/ Endoscopy Division
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL
+81-3-3542-2511
tamatsud@ncc.go.jp
Public contact
Name of contact person
| 1st name | Masau |
| Middle name | |
| Last name | Sekiguchi |
Organization
National Cancer Center Hospital
Division name
Cancer Screening Center/ Endoscopy Division
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL
+81-3-3542-2511
Homepage URL
masekigu@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
Tel
+81-3-3542-2511
irst@ml.res.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
国立がん研究センター中央病院（東京都）、広島大学（広島県）、東邦大学医療センター大橋病院（東京都）、石川県立中央病院（石川県）、佐野病院（兵庫県）、国立がん研究センター東病院（千葉県）、愛知県がんセンター中央病院（愛知県）、NTT東日本札幌病院（北海道）、北摂総合病院（大阪府）、宝塚市立病院（兵庫県）、大阪府立成人病センター（大阪府）、広島市立安佐市民病院（広島県）、斗南病院（北海道）、京都桂病院（京都府）、近畿大学（大阪府）、秋田赤十字病院（秋田県）、金沢医科大学（石川県）、四国がんセンター（愛媛県）、東京慈恵会医科大学（東京都）、静岡県立静岡がんセンター（静岡県）、JCHO大阪病院（大阪府）、NTT東日本関東病院（東京都）、赤坂内視鏡クリニック（東京都）、旭川医科大学（北海道）、岩手医科大学（岩手県）、岩手県立胆沢病院（岩手県）、大阪市立大学附属病院（大阪府）、大阪大学（大阪府）、岡山大学病院（岡山県）、尾田胃腸内科（熊本県）、香川大学医学部附属病院（香川県）、がん・感染症センター都立駒込病院（東京都）、がん研有明病院（東京都）、関西医科大学（大阪府）、北里大学病院（神奈川県）、九州大学（福岡県）、京都医療センター（京都府）、京都大学（京都府）、京都府立医科大学（京都府）、久留米大学消化器病センター（福岡県）、群馬中央病院（群馬県）、済生会吹田病院（大阪府）、堺市立総合医療センター（大阪府）、札幌医科大学医学部附属病院（北海道）、自治医科大学附属病院（栃木県）、市立旭川病院（北海道）、高槻赤十字病院（大阪府）、筑波大学附属病院（茨城県）、東京医科大学病院（東京都）、東京医療センター（東京都）、東京女子医科大学（東京都）、東京女子医大東医療センター（東京都）、東京大学（東京都）、徳島大学（徳島県）、栃木県立がんセンター（栃木県）、戸畑共立病院（福岡県）、新潟大学医歯学総合病院（新潟県）、兵庫医科大学（兵庫県）、広島市民病院（広島県）、弘前大学（青森県）、福岡大学筑紫病院（福岡県）、三重大学（三重県）、石川消化器内科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 10 | 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
502
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
| 2016 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 10 | Day |
Last modified on
| 2020 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029004
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/04/04 | 20210121 大腸NET Studyデータ固定用_update_20220317.xlsx |
