UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056850 |
|---|---|
| Receipt number | R000064975 |
| Scientific Title | COnsultation system of Nationwide oncology medical NEeds with online Communication Tool in Clinical Trials CONNECT-ClinicalTrials |
| Date of disclosure of the study information | 2025/01/28 |
| Last modified on | 2025/01/28 22:55:47 |
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Basic information
Public title
COnsultation system of Nationwide oncology medical NEeds with online Communication Tool in Clinical Trials CONNECT-ClinicalTrials
Acronym
CONNECT-ClinicalTrials
Scientific Title
COnsultation system of Nationwide oncology medical NEeds with online Communication Tool in Clinical Trials CONNECT-ClinicalTrials
Scientific Title:Acronym
CONNECT-ClinicalTrials
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Adult |
| Child |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study will establish an online consultation system using Join between medical institutions mainly in the Kanto region and the National Cancer Center Hospital, and share medical information of patients who wish to participate in clinical trials on Join in order to estimate the eligibility for clinical trials in advance,
To examine whether this system will contribute to promoting the inclusion of patients in clinical trials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients who were connected to a clinical trial within 3 months of referral, among patients who were referred to the National Cancer Center Hospital for clinical trials through the Join-based inquiry system.
Key secondary outcomes
1) Percentage of patients referred through this system who were referred to the National Cancer Center Hospital for clinical trials who were connected to a clinical trial proposed at the time of referral within 3 months after referral
2) Percentage of patients referred through this system who were referred to the National Cancer Center Hospital for clinical trials who were not connected to a clinical trial within 3 months after referral
3) Of the patients referred through this system and referred to the National Cancer Center Hospital for clinical trials, the percentage of patients who were connected to clinical trials (clinical trials and other clinical trials), the percentage of patients who were connected to clinical trials proposed at the time of referral, and the percentage of patients who were not connected to clinical trials
4) Number of patients referred through the system who participated in clinical trials and other clinical trials, phase of participating clinical trials, names of clinical trials (investigational drugs), patient age, gender, cancer type, number of treatment regimens, and other clinical information
5) Percentage of patients referred through the system who continued treatment at the referring hospital, and breakdown of these patients (those who visited the National Cancer Center Hospital, those who did not visit the hospital, and those who did not participate in proposed clinical trials)
6) Number of patients who received recommended treatment based on cancer genome profiling tests among patients referred through the system and who participated in clinical trials
7) Total number of patients whose clinical information was registered in the system, breakdown of cancer types
8) The period of review within the National Cancer Center Hospital (the number of days from inquiry to response on the system, converted into business days)
9) The number of cases reviewed in one week within the National Cancer Center Hospital
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients consulted through this system will be the target population.
Key exclusion criteria
None
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Kan |
| Middle name | |
| Last name | Yonemori |
Organization
National Cancer Center Hospital
Division name
1040045
Zip code
1040045
Address
5-1-1, Chuo-ku, Tokyo
TEL
0335422511
kyonemor@ncc.go.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Shimoi |
Organization
National Cancer Center Hospital
Division name
Department of Medical Oncology
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
tshimoi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Allm Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
ncch-irb@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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To establish an online consultation system using Join between medical institutions in the Kanto region and the National Cancer Center Hospital to share medical information of patients who wish to participate in clinical trials on Join, and to estimate the eligibility of patients for clinical trials in advance.
We will examine whether this system will contribute to promoting the inclusion of patients in clinical trials by sharing the medical information of patients who wish to participate in clinical trials on Join.
Management information
Registered date
| 2025 | Year | 01 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064975
