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Clinical Trials/NCT05139641
NCT05139641
Not yet recruiting
Not Applicable

Multidisciplinary Shared Decision Making of Fertility Preservation in Young Women With Breast Cancer

MedicalExcellence1 site in 1 country4,100 target enrollmentDecember 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Young Womenwith Breast Cancer
Sponsor
MedicalExcellence
Enrollment
4100
Locations
1
Primary Endpoint
selection ratio of fertility preservation procedure
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

Multidisciplinary shared decision making of fertility preservation in Young womenwith Breast Cancer (MYBC): A Pragmatic stepped wedge cluster randomised trial

Registry
clinicaltrials.gov
Start Date
December 2021
End Date
December 2028
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
MedicalExcellence
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women aged 19 to 40 years old
  • A person diagnosed with breast cancer by biopsy
  • Those who don't have evidence of distant metastasis
  • Eastern Cooperative Oncology Group(ECOG) performance status: 0-2 score
  • Before registering for clinical trials, chemotherapy, radiation therapy, anti-hormone therapy, immunotherapy, and surgery are not performed
  • A person who has fully understood and listened to the explanation of this clinical trial and then gave written consent

Exclusion Criteria

  • Histologically, a person diagnosed with follicular or sarcoma
  • Those with a history of breast cancer (including recurrent breast cancer)
  • A person diagnosed with another cancer before breast cancer
  • A person diagnosed with metastatic breast cancer
  • A person who has a mental illness and has a hard time understanding clinical trials
  • Those who plan to conduct follow-up observation elsewhere(to change of hometowm)
  • Menopausal factors without menstruation after more than a year from the last menstrual date
  • A pregnant woman
  • Inappropriate for participation in clinical trials

Outcomes

Primary Outcomes

selection ratio of fertility preservation procedure

Time Frame: selection ratio of fertility preservation procedure from Baseline to six years

Secondary Outcomes

  • The success rate of pregnancy(The success rate of pregnancy from Baseline to six years)

Study Sites (1)

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