Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313476
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-05
Brief Title:
AMH Predicts Postchemotherapy Menopause in Premenopausal Breast Cancer Patients
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
A Prospective Observational Clinical Study of AMH Predicting Postchemotherapy Menopause in Premenopausal Breast Cancer Patients Who do Not Use OFS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
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:
To determine the accuracy of AMH postchemotherapy in predicting permanent menopause after chemotherapy in breast cancer patients who did not use OFS before menopause
Detailed Description:
For early breast cancer women who are premenopausal after receiving chemotherapy neoadjuvant chemotherapy or adjuvant chemotherapy not using OFS as ovarian suppression AMH E2 and FSH levels will be measured by blood sampling before chemotherapy at the end of chemotherapy and 1 month 3 months 6 months 12 months 18 months and 24 months after chemotherapy The menstrual status of patients will be also followed up At several timing investigators will analyze AMH level E2 level FSH level proportion of unmeasured AMH AMH002ngml proportion of E2 that conforms to menopausal status E230ngL proportion of FSH that conforms to menopausal status FSH 30UL proportion of persistent amenia no menstruation from the end of chemotherapy to the evaluation time and incidence of adverse reactions
Study Oversight
Has Oversight DMC:
None
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?:
None