Gynecological MalignanciesNCT06151028
An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy
An observational study of Gynecological Malignancies and Menopausal Symptoms, run by Anhui Provincial Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecological Malignancies, Menopausal Symptoms, Bone Loss
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Provincal Hospital
Hefei, Anhui
Ying Zhou, caddie1234@gmail.com
About this study
Official title: An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy (Carnation1)
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.
Read the 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.
- Conditions
- Gynecological Malignancies, Menopausal Symptoms, Bone Loss
- Being tested
- No intervention
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study and did not involve interventions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Bone density examination
Measured: 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）
Measured: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
MENQOL
Menopause-Specific Quality of Life（0-174score）
Measured: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
HADS
Hospital Anxiety and Depression Scale（0-21score）
Measured: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
IOF
Osteoporosis Risk one-minute Test Scale (Yes or No)
Measured: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
PSQI
Pittsburgh sleep quality index（0-21score）
Measured: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
Secondary outcomes (2)
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.
Measured: 5 year
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.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Dec 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological MalignanciesStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ying Zhou, MD, Study chair, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151028
- Sponsor's protocol ID
- Ying Zhou
- Status last verified
- Oct 2023
- First submitted
- 3 Nov 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy (Carnation1)
- ClinicalTrials.gov ID
- NCT06151028
- Acronym / sponsor ID
- Ying Zhou
- Conditions
- Gynecological Malignancies, Menopausal Symptoms, Bone Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Premenopausal women with gynecological malignancies aged 18-55 years old;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study and did not involve interventions. | Other | – |
Primary outcome
Bone mineral density
Time frame: Bone mineral density was followed up at 1, 2, 3, 6, 9, 12, 24 and 36 months after the operation
Bone density examination
KMI
Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
Modified Kupperman Index（0-63score）
MENQOL
Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
Menopause-Specific Quality of Life（0-174score）
HADS
Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
Hospital Anxiety and Depression Scale（0-21score）
IOF
Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
Osteoporosis Risk one-minute Test Scale (Yes or No)
PSQI
Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
Pittsburgh sleep quality index（0-21score）
2 secondary outcomes
OS
Time frame: 5 year
PFS
Time frame: 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ying Zhou, MD study chair
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecological Malignancies and Menopausal Symptoms, run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zhou, MD (+8613865901025, caddiezy@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: Bone mineral density was followed up at 1, 2, 3, 6, 9, 12, 24 and 36 months after the operation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.