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Trial Title:
An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy
NCT ID:
NCT06151028
Condition:
Gynecological Malignancies
Menopausal Symptoms
Bone Loss
Conditions: Official terms:
Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
This is an observational study and did not involve interventions.
Summary:
Through long-term dynamic monitoring of gynecologic malignant tumor patients undergoing
early menopause after ovaries resection in our center, we explored the changes in
menopausal symptoms and bone health status of this population, and studied the effects of
platinum combined chemotherapy drugs on menopausal symptoms and bone loss in gynecologic
malignant tumor patients. To find the optimal time point and effective regimen for MHT in
gynecologic malignancies undergoing surgical menopause, and to provide guidance for
osteoporosis screening and prevention strategies in women with gynecologic cancer.
Detailed description:
Gynecological malignancies are affecting the health of more and more women in the world,
and the age of onset is also gradually younger. For women of reproductive age with
gynecologic malignancies, surgery involving bilateral ovariectomy, followed by
chemoradiotherapy or anti-estrogen therapy to maintain endocrine therapy, can lead to
early menopause, leading to earlier and more severe menopausal syndrome and bone loss.
Unlike the management of healthy women with natural menopause, the management of
prognosis and quality of life in cancer patients with early menopause resulting from
surgery combined with adjuvant therapy is more challenging and specific, and it is
critical to identify management options for this complex patient population.
This study aims to conduct long-term dynamic monitoring of patients with gynecologic
malignancies undergoing early menopause after ovaries resection in our center, explore
the changes in menopausal symptoms and bone health status of this population, and study
the effects of platinum combined chemotherapy drugs on menopausal symptoms and bone loss
in patients with gynecologic malignancies. To find out the best time point and effective
program of menopausal hormone therapy for gynecological malignant tumor patients with
surgical menopause, and provide guidance for osteoporosis screening and prevention
strategies for women with gynecological cancer.
Criteria for eligibility:
Study pop:
This study is an observational study. It is expected that the department will receive
about 3000 patients with gynecologic malignancies in the next 10 years. Based on this, we
plan to collect 490 premenopausal patients with gynecologic malignancies from the First
Affiliated Hospital of University of Science and Technology of China (Anhui Provincial
Hospital) during 2023.12~2033.12. All enrolled patients underwent standard tumor staging
or tumor cell reduction involving bilateral ovariectomy and completed follow-up therapy
(observation or chemotherapy) according to NCCN guidelines. The enrolled patients were
followed up regularly for tumor risk assessment, menopause scale assessment, bone health
assessment and related imaging examination. The medical history and data were complete.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Premenopausal women with gynecological malignancies aged 18-55 years old;
- Tumor types include endometrial cancer, cervical cancer, epithelial ovarian
cancer;
- All patients received standard stage operation and treatment;
- Patients with bilateral ovaries resection; ⑤Voluntarily participate
in this study, willing to sign informed consent, and have long-term
follow-up conditions.
Exclusion Criteria:
- Menopause (women over 40 years of age stop menstruation for 12 months, excluding
pregnancy and other diseases that may cause amenorrhea can be clinically diagnosed
as menopause); Or AMH < 0.2ng/ml (China Menopause Management and Menopause Hormone
Therapy Guidelines 2023 edition); Or FSH> 40 mIU/ml after two checks within one
month;
- Other tumors were combined within 2 years and were still in radiotherapy,
chemotherapy or hormone therapy;
- Diagnosis of immunodeficiency disease or active hepatitis B, C, active
tuberculosis; ④Serious organic diseases of the organs, etc., can not
cooperate with the study follow-up; ⑤Long-term use of hormonal drugs for
rheumatic system diseases, such as glucocorticoids;
- Patients who have previously received pelvic or abdominal
radiotherapy; ⑦ ECOG score ≥3 points; ⑧The patient did not sign
informed consent or was unwilling to accept follow-up interviews.
Gender:
Female
Minimum age:
18 Years
Maximum age:
55 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Anhui Provincal Hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Zhou
Email:
caddie1234@gmail.com
Start date:
December 1, 2023
Completion date:
December 31, 2033
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06151028
