Health TrialsbyHealthPanel

An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy

ConditionsGynecological MalignanciesMenopausal SymptomsBone Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorAnhui Provincial Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    This is an observational study and did not involve interventions.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Bone mineral density

Bone density examination

Time frame
Bone mineral density was followed up at 1, 2, 3, 6, 9, 12, 24 and 36 months after the operation
2

KMI

Modified Kupperman Index（0-63score）

Time frame
The scale was evaluated at 1, 3, 6 and 12 months after surgery.
3

MENQOL

Menopause-Specific Quality of Life（0-174score）

Time frame
The scale was evaluated at 1, 3, 6 and 12 months after surgery.
4

HADS

Hospital Anxiety and Depression Scale（0-21score）

Time frame
The scale was evaluated at 1, 3, 6 and 12 months after surgery.

Secondary outcomes

1

OS

OS was defined as the time interval between a patient's diagnosis of gynecologic malignancy and death from any cause or the end of the last follow-up date.

Time frame
5 year
2

PFS

PFS is defined as the time interval between a patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.

Time frame
5 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anhui Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov
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