UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060507 |
|---|---|
| Receipt number | R000069221 |
| Scientific Title | Observational study to develop a psychosocial impact assessment scale for patients undergoing comprehensive cancer genomic profiling testing |
| Date of disclosure of the study information | 2026/01/29 |
| Last modified on | 2026/01/29 10:14:40 |
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Basic information
Public title
Developing a scale to assess the psychosocial impact of comprehensive cancer genomic profiling testing
Acronym
S-CAT
Scientific Title
Observational study to develop a psychosocial impact assessment scale for patients undergoing comprehensive cancer genomic profiling testing
Scientific Title:Acronym
S-CAT
Region
| Japan |
Condition
Condition
Advanced cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Obstetrics and Gynecology | Dermatology |
| Oto-rhino-laryngology | Urology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the validity and reliability of the Multidimensional Impact of Cancer Risk Assessment for Comprehensive Genomic Profiling (MICRA-CGP), a scale developed to assess the psychosocial impact following the disclosure of comprehensive cancer genomic profiling (CGP) test results, in patients who have undergone CGP testing.
Basic objectives2
Others
Basic objectives -Others
The validity and reliability of the MICRA-CGP.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Multidimensional Impact of Cancer Risk Assessment for Comprehensive Genomic Profiling (MICRA-CGP)
Key secondary outcomes
Patient Health Questionnaire-9(PHQ-9)
General Anxiety Disorder-7(GAD-7)
*Impact of Event Scale(IES)
*Patient Satisfaction
*Questionnaire(PSQ)
*Family APGAR
*Medical background: cancer type, disease stage(presence or absence of distant metastasis and recurrence), duration of clinical care
*Sociodemographic background: age, marital status, presence or absence of children, employment status, household income, and educational level
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*Patients receiving care at the National Cancer Center Hospital(Chuo Hospital and East Hospital), Tochigi Cancer Center, Juntendo University Hospital, Yokohama Municipal Citizen's Hospital, Toyama Prefectural Central Hospital, Nagoya City University Hospital, University Hospital,Kyoto Prefectural University of Medicine, Keio University Hospital, Tokyo Metropolitan Komagome Hospital, or Kanagawa Cancer Center
*Patients who have been diagnosed with solid tumors and have received an explanation of their diagnosis from healthcare professionals, and for whom the attending physician judges that a basic understanding of the disease has been obtained
*Patients who are able to read and understand Japanese study documents and questionnaires and complete them independently
*Patients aged 18 years or older
Key exclusion criteria
*Individuals with difficulty reading or writing Japanese
*Individuals deemed inappropriate for participation by the principal investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Fujimori |
Organization
National Cancer Center Institute for Cancer Control
Division name
Division of Supportive Care, Survivorship and Translational Research
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045 JAPAN
TEL
03-3547-5201(3328)
mfujimor@ncc.go.j
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Fujimori |
Organization
National Cancer Center Institute for Cancer Control
Division name
Division of Supportive Care, Survivorship and Translational Research
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045 JAPAN
TEL
03-3547-5201(3328)
Homepage URL
mfujimor@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Institute for Cancer Control
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
*Tochigi Cancer Center
*Juntendo University Hospital
*Yokohama Municipal Citizen's Hospital
*Toyama Prefectural Central Hospital
*Nagoya City University Hospital
*University Hospital, Kyoto Prefectural University of Medicine
*Keio University Hospital
*Tokyo Metropolitan Komagome Hospital
*Kanagawa Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional review board
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
Tel
03-3542-2511
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 29 | 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
| 2025 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2026 | Year | 01 | Month | 29 | Day |
Last modified on
| 2026 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069221
