Actively Recruiting
An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy (Carnation1)
Led by Anhui Provincial Hospital · Updated on 2024-03-07
490
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to monitor women with gynecologic cancers who experience early menopause after having their ovaries removed. The study looks at how menopausal symptoms and bone health change over time in these patients. It also examines how platinum-based chemotherapy drugs may affect menopausal symptoms and bone loss. The goal is to identify the best timing and effective hormone therapy programs for these women and to guide osteoporosis screening and prevention strategies. This is an observational study where patients receive no specific intervention as part of the trial. Researchers will follow these women after their surgery, tracking changes in their bone mineral density and symptoms related to menopause using various scales. Patients are observed over multiple time points up to 36 months post-operation to gather comprehensive data about their health status. Participants will undergo regular assessments including bone mineral density tests and evaluations of menopausal symptoms, mood, sleep quality, and osteoporosis risk at intervals from 1 month to 3 years after surgery. The study also tracks longer-term outcomes like overall survival and progression-free survival over 5 years. This thorough monitoring helps researchers understand the effects of surgery and chemotherapy on these patients' quality of life and bone health.
CONDITIONS
Brief Title
An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premenopausal women aged 18 to 55 years
- Diagnosed with gynecological malignancies including endometrial cancer, cervical cancer, or epithelial ovarian cancer
- Have undergone standard stage operation and treatment
- Have had both ovaries surgically removed
- Willing to voluntarily participate and able to commit to long-term follow-up
You will not qualify if you...
- Women diagnosed with menopause (12 months without menstruation over age 40) or with specific hormone levels indicating menopause
- Receiving radiotherapy, chemotherapy, or hormone therapy for other tumors diagnosed within the last 2 years
- Diagnosed with immunodeficiency disease, active hepatitis B or C, or active tuberculosis
- Have serious organ diseases preventing study follow-up
- Long-term use of hormonal drugs for rheumatic diseases such as glucocorticoids
- Previously received pelvic or abdominal radiotherapy
- ECOG performance status score of 3 or higher
- Unwilling to sign informed consent or participate in follow-up interviews
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Initial period after surgery
Participants undergo surgical removal of both ovaries and receive immediate post-operative care.
Duration - Up to 3 years
Participants are monitored over time to observe changes in menopausal symptoms and bone health following surgery.
Visits at 1, 2, 3, 6, 9, 12, 24, and 36 months post-surgery
Trial Site Locations
Total: 1 location
1
Anhui Provincal Hospital
Hefei, Anhui, China
Actively Recruiting
Research Team
Y
Ying Zhou, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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