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.
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.
Study Type
OBSERVATIONAL
Enrollment
2,000
Taizhou Central Hosipital
Taizhou, Zhejiang, China
The overall-surviva(OS) period of childbirth after diagnosis
The starting time of OS regarded as after completing the childbearing behavior.Death is regarded as the end time of OS.
Time frame: About 2 years after the start of the research.
The disease-free survival(DFS) period of childbirth after diagnosis
The starting time of DFS is regarded as after completing the childbearing behavior.Repase or distant metastasis is regarded as the end time of DFS.
Time frame: About 2 years after the start of the research
The growth and development of offspring
The growth and development of young breast cancer patients after diagnosis. By collecting their height, weight and other data, using the Lambda-Mu-Sigma method recommended by WHO, the obtained data is fitted to the offspring growth curve of young breast cancer patients and compared with the standard curve, in order to evaluate whether the patients' offspring grows abnormally.
Time frame: About 2 years after the start of the research
The occurrence of diseases in the descendants of young breast cancer patients.
Descriptive research. Describe the number of serious disease events in the offspring of young breast cancer patients after diagnosis, such as the number of secondary tumors in childhood
Time frame: About 2 years after the start of the research
Fertility rate of young breast cancer patients.
The ratio of the number of young breast cancer patients giving birth after diagnosis to the total number of samples included.
Time frame: About 2 years after the start of the research.
Complications during pregnancy after diagnosis of young breast cancer patients.
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Descriptive research. Describe the complications during pregnancy after the diagnosis of young breast cancer patients, and describe the specific types and proportion of complications.
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.
Descriptive research. Count the proportion of young breast cancer patients who use fertility preservation technology during pregnancy after diagnosis.
Time frame: About 2 years after the start of the research
Breastfeeding.
It mainly describes the proportion of patients breastfeeding and whether there are any difficulties due to the disease in the process.
Time frame: About 2 years after the start of the research.