UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049238 |
|---|---|
| Receipt number | R000056078 |
| Scientific Title | Feasibility study to establish a real-world database on the actual treatment of unresectable advanced or metastatic gastric cancer using CyberOncology |
| Date of disclosure of the study information | 2022/10/18 |
| Last modified on | 2024/04/18 11:02:41 |
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Basic information
Public title
CyberOncology Network Project: a supplementary study
Acronym
CONNECT: a supplementary study
Scientific Title
Feasibility study to establish a real-world database on the actual treatment of unresectable advanced or metastatic gastric cancer using CyberOncology
Scientific Title:Acronym
CONNECT: a supplementary study
Region
| Japan |
Condition
Condition
unresectable advanced or metastatic gastric cancer
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 (CyberOncology) to collect real-world data on cancer treatment in unresectable advanced or recurrent gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Multicenter integrated data
1. HER2 testing rate
2. MSI testing rate
3. Percentage of patients receiving chemotherapy (by treatment line)
4. Chemotherapy regimen (per treatment line)
5. Patient background (organ function, comorbidities, medical history, etc.)
6. Response rate (RECIST ver 1.1)
7. Disease control rate (RECIST ver 1.1)
8. Progression-free survival
9. Successful treatment period
10. Overall survival
11. Adverse events (CTCAE ver 5.0)
12. Serious adverse events
Key secondary outcomes
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
1) Histologically confirmed epithelial malignancy.
2) Unresectable advanced or recurrent disease.
3) Primary tumor is located in the stomach or esophagogastric junction (Siewert type II-III).
4) The patient is scheduled to receive cancer chemotherapy at the participating institution (regardless of the line of therapy).
5) Consent to participate in this study has been obtained.
Key exclusion criteria
Cases that the researcher deems inappropriate for participating in this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Muro |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, JAPAN
TEL
052-762-6111
kmuro@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Kadowaki |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, JAPAN
TEL
052-762-6111
Homepage URL
skadowaki@aichi-cc.jp
Sponsor or person
Institute
Department of Clinical Oncology, Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Review Committee, Aichi Cancer Center Hospital
Address
1-1 Kanokoden, Chikusaku, Nagoya, JAPAN
Tel
052-762-6111
irb-jimu@aichi-cc.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 18 | 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
100
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
| 2021 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
<Technical support, data maintenance, etc.>
New Medical Real World Data Research Organization Co., Ltd. (PRiME-R)
Management information
Registered date
| 2022 | Year | 10 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056078
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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