UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053185 |
|---|---|
| Receipt number | R000060698 |
| Scientific Title | Patient Survey on Diagnosis and Treatment of Breast Cancer in Adolescent and Young Adults |
| Date of disclosure of the study information | 2023/12/21 |
| Last modified on | 2023/12/21 14:37:49 |
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Basic information
Public title
Patient Survey on Diagnosis and Treatment of Breast Cancer in Adolescent and Young Adults
Acronym
Patient Survey on Diagnosis and Treatment of Breast Cancer in AYAs
Scientific Title
Patient Survey on Diagnosis and Treatment of Breast Cancer in Adolescent and Young Adults
Scientific Title:Acronym
Patient Survey on Diagnosis and Treatment of Breast Cancer in AYAs
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the clinical characteristics and treatment status of AYA breast cancer in Japan. Specifically, if factors leading to delayed diagnosis are identified, the information can be utilized for educational activities promoting early diagnosis. Moreover, if it is found that adequate treatment, such as genetic testing and fertility preservation, is not currently being provided for AYA breast cancer patients, this study can serve as important evidence to advocate for such treatments in the future.
Basic objectives2
Others
Basic objectives -Others
Patient survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cancer stage at the time of diagnosis
Key secondary outcomes
Factors leading to breast cancer diagnosis
Time from the appearance of self-aware symptoms (or detection of abnormalities in screening) to diagnosis
Period during which the patient felt most distressed after being diagnosed with breast cancer
Barriers to receiving good treatment for breast cancer
Understanding of explanations from healthcare professionals
Existence of explanations from healthcare professionals regarding genetic testing
Existence of explanations from healthcare professionals regarding fertility preservation
Existence of explanations from healthcare professionals regarding breast reconstruction
Base
Study type
Others,meta-analysis etc
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
| 15 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosed with breast cancer between the ages of 15 and 39
Time from diagnosis to questionnaire response is within 10 years
Agreed to participate in this study
Key exclusion criteria
Undergoing breast cancer treatment primarily in other countries
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Ueno |
Organization
Kurashiki Central Hospital
Division name
Department of General Surgery
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
aya.breast.cancer@outlook.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Ueno |
Organization
Kurashiki Central Hospital
Division name
Department of General Surgery
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
https://www.kchnet.or.jp/kchnet/wp-content/uploads/aya_breast_cancer.pdf
aya.breast.cancer@outlook.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
AYA Oncology Alliance
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Central Hospital, Medical Ethics Committee
Address
Miwa 1-1-1, Kurashiki, Okayama
Tel
086-422-0210
kenkyu@kchnet.or.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
倉敷中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 21 | 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
| 2023 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Questionnaire-based study (survey)
Management information
Registered date
| 2023 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060698
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
