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NCT Number: NCT05139641

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

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

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Key information

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical Excellence

Seoul, South Korea

Location contact

Heejeong Kim, MD

PRINCIPAL_INVESTIGATOR

Minjung Kim

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling to preserve fertility

Behavioral

Counseling to preserve fertility VS Control group

Primary outcomes

  1. selection ratio of fertility preservation procedure

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

Secondary outcomes

  1. The success rate of pregnancy

    Time frame: The success rate of pregnancy from Baseline to six years

Study contacts

Contact information is provided by the study sponsor or research team.

Minjung Kim

CONTACT

[email protected]

82-2-3482-7809

Sponsors and collaborators

Lead sponsor

MedicalExcellence

Other

Collaborators

  • Asan Medical Center

Registry information

Acronym: MYBC

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Dec 1, 2021
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.