Fertility Outcomes In Young Breast Cancer Patients And Their Prognosis And Offspring Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prognosis, Fertility, Breast Cancer, Young People. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to clarify the fertility status of young breast cancer patients, verify the independent impact of fertility behavior on the prognosis of patients with different molecular types, and evaluate the association between treatment regimens and offspring health.
Detailed description
This was a multicenter retrospective study on fertility outcomes and their prognosis and offspring health in young breast cancer patients. Based on the breast cancer database, the investigators registered the baseline data of young breast cancer patients (≤40 years old), including age at initial diagnosis, molecular typing, tumor stage, treatment plan, fertility protection measures, etc., and followed up by telephone/email and other means to collect their fertility status, recurrence and offspring growth and development data. The primary endpoints were the disease-free survival (DFS), overall survival (OS) after childbirth and childrens' growth and development. The secondary endpoints were the patient's fertility live birth rate, pregnancy outcomes and complications, use of fertility preservation techniques, breastfeeding status, etc. The investigators used the Kaplan-Meier method to draw the survival curve of the patients after childbirth, and analyzed the growth trajectory of the offspring born after diagnosis by the Lambda-Mu-Sigma method, and plotted the growth and development curve.The investigators used Log-rank to test the significance of differences in pregnancy rates between variables. The investigators used Univariate Cox regression analysis to screen factors related to prognosis, and then used multivariate Cox regression analysis to adjust for potential confounding factors to clarify independent prognostic indicators of disease. Finally, descriptive analyses were performed for other secondary outcomes.
Primary outcome measures
- The overall-surviva(OS) period of childbirth after diagnosis [Time frame: About 2 years after the start of the research.]
- The disease-free survival(DFS) period of childbirth after diagnosis [Time frame: About 2 years after the start of the research]
- The growth and development of offspring [Time frame: About 2 years after the start of the research]
- The occurrence of diseases in the descendants of young breast cancer patients. [Time frame: About 2 years after the start of the research]
Secondary outcome measures (4)
- Fertility rate of young breast cancer patients. [Time frame: About 2 years after the start of the research.]
- Complications during pregnancy after diagnosis of young breast cancer patients. [Time frame: About 2 years after the start of the research]
- The use of fertility preservation in the reproductive process of young breast cancer patients. [Time frame: About 2 years after the start of the research]
- Breastfeeding. [Time frame: About 2 years after the start of the research.]
Eligibility criteria
Inclusion criteria
Only subjects who meet all of the following inclusion criteria can be enrolled in this trial:
- Female patients diagnosed with breast cancer aged ≤ 40 years;
- Patients with pathologically confirmed breast cancer, and TNM stage 0-III, the disease is in a stable or progressive state;
- Complete medical records and clinical follow-up data were available. Informed consent.
Exclusion criteria
Anyone who has one of the following conditions cannot be included in this trial:
- Female patients with a diagnosis age>40 years;
- Stage IV breast cancer at first diagnosis;
- The presence of other reproductive system diseases caused by oligomenorrhea or amenorrhea and infertility; Loss of clinical data or loss to follow-up.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Taizhou Central Hosipital — Taizhou
Identifiers
NCT: NCT07376681 · ZYuzhu