UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044646 |
|---|---|
| Receipt number | R000049137 |
| Scientific Title | Multicenter cohort study on real-world data collection in cancer treatment. |
| Date of disclosure of the study information | 2021/06/24 |
| Last modified on | 2022/12/28 16:55:08 |
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Basic information
Public title
CyberOncology Network Project
Acronym
CONNECT
Scientific Title
Multicenter cohort study on real-world data collection in cancer treatment.
Scientific Title:Acronym
CONNECT
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To examine the feasibility of a system that collects real-world data on cancer treatment.
Basic objectives2
Others
Basic objectives -Others
to examine the feasibility of a secure system that integrates and analyzes real-world data collected from multiple facilities.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Own data
1) Statistical data
(A) Cancer type (OncoTree, ICD-O-3): Number of patients (new / total) / diagnosis date
(B) Chemotherapy (number / content): Patient (new / total), drug, regimen
(C) Basic patient information: age, gender, PS, cStage (TNM), race
(D) Treatment method (number / content): Chemotherapy / surgery / radiation
2) Treatment results
(A) Progression-free survival (postoperative chemotherapy is recurrence-free survival): Cancer type, line, regimen
(B) Successful treatment period: Cancer type, line, regimen
(C) Overall survival: cancer type, line, regimen
(D) Response rate: Cancer type, line, regimen
3) Adverse events
(A) Cancer type / line / regimen
(B) SAE report
Key secondary outcomes
Multicenter integrated data
1) Statistical data
(A) Cancer type (OncoTree, ICD-O-3): Number of patients (new / total) / diagnosis date
(B) Chemotherapy (number / content): Patient (new / total), drug, regimen
(C) Basic patient information: age, gender, PS, cStage (TNM), race
(D) Treatment method (number / content): Chemotherapy / surgery / radiation
2) Treatment results
(A) Progression-free survival (postoperative chemotherapy is recurrence-free survival): Cancer type, line, regimen
(B) Successful treatment period: Cancer type, line, regimen
(C) Overall survival: cancer type, line, regimen
(D) Response rate: Cancer type, line, regimen
3) Adverse events
(A) Cancer type / line / regimen
(B) SAE report
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients with solid tumors who are eligible for cancer chemotherapy.
Cases for which consent was obtained to participate in this study.
Key exclusion criteria
Cases that the researcher deems inappropriate for participating in this study.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Muto |
Organization
Kyoto University
Division name
Department of Therapeutic Oncology, Graduate School of Medicine
Zip code
606-8507
Address
54 Shogoinkawara-cho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-751-4592
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigemi |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyoto University
Division name
Department of Real world data R& D, Graduate School of Medicine
Zip code
606-8507
Address
54 Shogoinkawara-cho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-751-4349
Homepage URL
motocame@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
京都大学医学部附属病院
＜共同研究機関・共同研究実施場所＞
1. 和歌山県立医科大学附属病院
2. 千葉県立がんセンター
3. 愛媛大学医学部附属病院
4. 長崎大学病院
5. 千葉大学医学部附属病院
6. 慶應義塾大学病院
7. 佐賀大学病院
8. 滋賀県立総合病院
9. 杏林大学病院
10. 四国がんセンター
11. 東京医科大学病院
12. 藤田医科大学病院
13. 金沢大学医学部附属病院
14. 福井大学医学部附属病院
15. 神奈川県立がんセンター
16. 兵庫県立がんセンター
17. 広島大学病院
18. 宮崎大学医学部附属病院
19. 聖マリアンナ医科大学
20. 愛知県がんセンター
21. 大阪赤十字病院
22. 北海道大学病院
23. 神戸市立医療センター中央市民病院
24. 名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 24 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Technical support, data maintenance, etc.>
New Medical Real World Data Research Organization Co., Ltd. (PRiME-R)
Management information
Registered date
| 2021 | Year | 06 | Month | 24 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049137
