Taizhou Central Hosipital
Taizhou, Zhejiang, China
NCT Number: NCT07376681
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.
Interested in participating?
Request Info18 year–40 year
Female
Observational
Taizhou, Zhejiang, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Only subjects who meet all of the following inclusion criteria can be enrolled in this trial:
Exclusion criteria
Anyone who has one of the following conditions cannot be included in this trial:
Time frame: About 2 years after the start of the research.
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 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 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
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.
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
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
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.
It mainly describes the proportion of patients breastfeeding and whether there are any difficulties due to the disease in the process.
Taizhou Hospital
Other
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