UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034481 |
|---|---|
| Receipt number | R000039318 |
| Scientific Title | Hope for YBC project: A prospective cohort study of young women with breast cancer |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2021/04/16 13:13:32 |
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Basic information
Public title
Hope for YBC project: A prospective cohort study of young women with breast cancer
Acronym
Hope for YBC project
Scientific Title
Hope for YBC project: A prospective cohort study of young women with breast cancer
Scientific Title:Acronym
Hope for YBC project
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safty and feasibility of fertility preservation before chemotherapy and outcome of pregnancy after breast cancer treatment.
To explore psycosocial effect about fertility concern for young breast cancer patients
To identfy specific biomakaer for young woman with breast cancer and pregnancy-associated breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Consultation rate of fertility preservation
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1 Breast cancer diagnosis <=20 to <40ys
2 Stage 0-IIIC
3 Operation of primary breast cancer is scheduled or is done (before chemotherapy or endocrine therapy)
4 Written informed consent is obtained
Key exclusion criteria
1 Patients who are judged as ineligible for the study enrollment by investigators
2 Patients who are unable to willing pregnant by any medical reason.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Chikako |
| Middle name | |
| Last name | Shimizu |
Organization
Center Hospital of the National Center for Global Health and Medicine
Division name
Breast center
Zip code
162-8655
Address
1-21-1Toyama,Shinjuku-ku,Tokyo
TEL
03-3202-7188
cshimizu@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Watanabe |
Organization
Showa University
Division name
School of Nursing and Rehabilitation Sciences
Zip code
226-8554
Address
1865 tokaichibamachi,midoriku,yokohama.Kanagawa
TEL
045-985-6532
Homepage URL
chiew@med.showa-u.ac.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1Toyama Shinjuku-ku
Tel
03-3202-7188
kenkyu-shinsa@hosp.ncgm.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
国立国際医療研究センター病院（東京都）
筑波大学附属病院（茨城県）
岡山大学（岡山県）
九州がんセンター（福岡県）
昭和大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: A prospective non-interventional observational study
Management information
Registered date
| 2018 | Year | 10 | Month | 13 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039318
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
