Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-27 @ 5:01 AM
Study NCT ID:
NCT03543059
Status:
UNKNOWN
Last Update Posted:
2018-06-01
First Post:
2018-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Premenopausal Breast Cancer Patients
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Premenopausal Women With Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer is one of the most common malignant tumor in women. About 60% of breast cancer patients are still in premenopausal status at the time of diagnosis in China. It is a multicenter prospective observational study. We will collect basic information, medical history, chemotherapy-related adverse reactions, and the results of hormone, blood lipid, and bone density test before, during and after adjuvant or neoadjuvant chemotherapy. The aim of the study is to evaluate the effect of chemotherapy on ovarian function and fertility and the protective effect of GnRHa. In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.
Detailed Description:
Breast cancer is one of the most common malignant tumor in women, and it occurs at a younger median age in Chinese women than in western white women. About 60% of breast cancer patients are still in premenopausal status at the time of diagnosis in China. Chemotherapy is one of the important treatments for breast cancer, but it brings a series of adverse effects. It is a multicenter prospective observational study. The premenopausal breast cancer women patients who are planning adjuvant or neoadjuvant chemotherapy are enrolled in the study after signing the informed consent form and passing the screening. We collect their basic information, medical history, chemotherapy-related adverse reactions, and the results of hormone, blood lipid, and bone density test before, during and after chemotherapy. The aim of the study is to evaluate the effect of adjuvant or neoadjuvant chemotherapy on ovarian function and fertility and the protective effect of GnRHa by investigating the menopausal symptoms, pregnancy, menstruation condition, hormone levels, blood lipid, bone density, and the usage of GnRHa in the premenopausal women with breast cancer. In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: