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

NCT06151028 | Recruiting

• 1 other identifier: Ying Zhou
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecological Malignancies; Menopausal Symptoms; Bone Loss

Outcome Measures

Primary Outcomes (6)

• Bone mineral density

  Bone density examination

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

• KMI

  Modified Kupperman Index（0-63score）

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

• MENQOL

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

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

• HADS

  Hospital Anxiety and Depression Scale（0-21score）

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

• IOF

  Osteoporosis Risk one-minute Test Scale (Yes or No)

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

• PSQI

  Pittsburgh sleep quality index（0-21score）

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

Secondary Outcomes (2)

• OS

  5 year

• PFS

  5 year

Interventions

No intervention OTHER

This is an observational study and did not involve interventions.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provincal Hospital

Hefei, Anhui, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual Blood, Urine, Fecal, Saliva

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ying Zhou, MD

  The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

  STUDY CHAIR

Central Study Contacts

Ying Zhou, MD

CONTACT

+8613865901025; caddiezy@ustc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 30, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: March 7, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)