UMIN-CTR Clinical Trial

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

malignant tumor

Classification by specialty

Hematology and clinical oncology

Adult

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

mmuto@kuhp.kyoto-u.ac.jp

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

Email

motocame@kuhp.kyoto-u.ac.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

Kyoto University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2021

Year

06

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

<Technical support, data maintenance, etc.>
New Medical Real World Data Research Organization Co., Ltd. (PRiME-R)

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