UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047067 |
|---|---|
| Receipt number | R000053691 |
| Scientific Title | A prospective observational study to explore the impact of risk-reducing mastectomy and surveillance on mental and psychological status and quality of life in patients with hereditary breast and ovarian cancer |
| Date of disclosure of the study information | 2022/03/03 |
| Last modified on | 2022/03/03 18:26:20 |
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Basic information
Public title
A prospective observational study to explore psychological status and quality of life in patients with hereditary breast and ovarian cancer
Acronym
MentaQ trial
Scientific Title
A prospective observational study to explore the impact of risk-reducing mastectomy and surveillance on mental and psychological status and quality of life in patients with hereditary breast and ovarian cancer
Scientific Title:Acronym
MentaQ trial
Region
| Japan |
Condition
Condition
Hereditary breast and ovarian cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the medium- to long-term changes in mental and psychological status and quality of life from the disclosure of BRCA genetic test results to the decision to choose of risk reduction strategies and the implementation of surveillance or risk-reducing mastectomy.
Basic objectives2
Others
Basic objectives -Others
Supporting decision-making for risk reduction strategies in patients with hereditary breast and ovarian cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chronological changes in PHQ-9 scores
Key secondary outcomes
1) Chronological changes in GAD-7 scores
2) Chronological changes in SF-36 scores
3) Clinical background factors and their relevance to decision making on risk reduction strategies
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Women who have developed breast or ovarian cancer with a pathological variant of BRCA1 or BRCA2 confirmed by BRCA genetic testing
2) Patients scheduled for risk-reducing mastectomy or imaging surveillance including contrast-enhanced MRI as a risk reduction strategy (with or without risk-reducing salpingo-oophorectomy)
3) Women over 20 years old
Key exclusion criteria
1) Bilateral breast cancer patients
2) Patients with metastasis or recurrence
3) Patients with active multiple primary cancers
4) Patients with contraindications to MRI examinations and the use of contrast media
5) Patients deemed inappropriate by the physician in charge of treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Rurina |
| Middle name | |
| Last name | Watanuki |
Organization
National Cancer Center Hospital East
Division name
Department of Breast Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577 Japan
TEL
04-7133-1111
rwatanuk@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Onishi |
Organization
National Cancer Center Hospital East
Division name
Department of Breast Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577 Japan
TEL
04-7133-1111
Homepage URL
taonishi@east.ncc.go.jp
Sponsor or person
Institute
Department of Breast Surgery, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East Certified Review Board
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577 Japan
Tel
04-7133-1111
ncche-irb@east.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
国立がん研究センター東病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Assessment of mental and psychological status and quality of life over time using a questionnaire from the time of diagnosis of hereditary breast and ovarian cancer by BRCA genetic testing
Management information
Registered date
| 2022 | Year | 03 | Month | 03 | Day |
Last modified on
| 2022 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053691
