All Conditions

Menopause

This is an observational study and did not involve interventions.

No intervention

Ying Zhou, MD

Ying Zhou

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.

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.

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

An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy (Carnation1)

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

Hospital Anxiety and Depression Scale（0-21score）

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

Pittsburgh sleep quality index（0-21score）

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.

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.

Anhui Provincial Hospital

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants received BL-B01D1, SI-B003 or BL-B01D1 + SI-B003 therapy in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.

BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.

BL-B01D1

SI-B003 was administered by intravenous infusion every 3 weeks (Q3W).

SI-B003

Hai Zhu, PHD

Sa Xiao, PHD

Lingying Wu

Lingying Wu, PHD

Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination.

Objective: To explore the efficacy of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical cancer. To explore the safety and tolerability of BL-B01D1 monotherapy, SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination therapy.

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies

ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study .

The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred first.

The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).

The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Sichuan Baili Pharmaceutical Co., Ltd.

Skin and Connective Tissue Diseases

Digestive System Diseases

Breast Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Breast Diseases

Skin Diseases

Gastrointestinal Diseases

Empegfilgrastim

Lyudmila Zhukova, MD, PhD, professor

Alexey Tryakin, MD, PhD, professor

Inna Ganshina, MD, PhD

Mikhail Fedyanin, MD, PhD, professor

Svetlana Khlokhlova, MD, PhD

Svetlana Khokhlova, MD, PhD

This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies

A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations

Defendor Special: A Multicenter Prospective Observational Post-registration Study of Combined Chemotherapy With Empegfilrastim Support to Evaluate Safety and Efficacy in Patients With High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies

Moscow Clinical Scientific Center

Deputy Director of the Loginov Moscow Clinical Scientific Center, MD, PhD, Professor

Ileus

Herbal and Botanical

All Drugs and Chemicals

Peppermint

Gum type was standardized with all subjects receiving sugar-free peppermint-flavored gum.

The patients in the chewing gum group, gum chewing began the morning of postoperative day 1. Patients chewed gum (one stick) 3 times daily in the morning, afternoon, and evening at least 5 min. The administration of the therapy was implemented by ward nursing staff and recorded in the patients file. All gum-chewing patients completed their course of gum chewing until bowel function.

Egemen Ertas, M.D

Aykut Ozdemir, M.D

Egmen Ertas, drertas@gmail.com

Postoperative ileus can cause the accumulation of secretions and gas, resulting in nausea, vomiting and abdominal distension and pain. Prolonged paralytic ileus is one of the commonest reasons for delayed recovery and discharge from hospital following abdominal surgery. Advances in surgical techniques and peri-operative management such as the use of laparoscopic surgery, thoracic epidural analgesia, early postoperative feeding and mobilization, amongst others, have been shown to help in the resolution of postoperative ileus.

Chewing gum, as a proxy for sham feeding, may accelerate the motility of the GI tract by stimulating the cephalic phase of digestion and eliciting the release of multiple promotility GI hormones. A number of small controlled studies evaluating the effect of chewing gum on postoperative intestinal recovery in patients undergoing colorectal surgery have been conducted. Decreased time for bowel function recovery and decreased hospital length of stay have not been consistently documented, possibly owing to the insufficient power of existing studies and study design issues. In addition, all previous studies have been limited by their use of sugarfree gum, containing known motility agents (eg, sorbitol).

In this study, gum chewing was studied for its effect on women with surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer.

Influence of Gum Chewing on Postoperative Bowel Activity After Complete Staging Surgery for Gynecological Malignancies

The main outcome variable of the study was postoperative flatus pass time (hours from end of operation). Participants will be followed for the duration of the flatus pass time, an expected average of 48 hours

Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

gastrointestinal disturbance such as nausea, abdominal cramping, abdominal distension, rate of vomiting

time to first bowel movement (hours from end of operation).Participants will be followed for time to first bowel movement, an expected average of 48 hours hours from end of operation

The main outcome variable of the study was postoperative flatus pass time (hours from end of operation).Participants will be followed for the duration of the first defaecation time, an expected average of 72 hours

Erzincan Military Hospital

Medical Doctor

Gland and Hormone Related Diseases

Blood and Lymph Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Anemia

Hematologic Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Hematinics

Epoetin Alfa

Darbepoetin alfa

darbepoetin alfa

recombinant human erythropoietin (rHuEPO)

The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in gynecological cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.

Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy

An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patients With Gynecological Malignancies Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy

Amgen

Global Development Leader

Vulvar Neoplasms

Endometrial Neoplasms

Vulvar Diseases

Vulvar Cancer

Immunomodulating Agents

Chemotherapy in combination with immunotherapy

Dominik Dannehl, Dr.

Tobias Engler, Dr.

ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).

Immunotherapy, which involves activating the body's immune system for cancer treatment, has already been widely incorporated into the standard care of patients with advanced and metastatic gynecological cancers.

This study aims to investigate how inflammatory markers such as C-reactive protein (CRP) change during and after immunotherapy. Study findings from other tumor types (kidney, lung, bladder) suggest that immunotherapy is particularly effective when a mild inflammatory response is triggered in the body. The investigators want to examine this using CRP measurement. CRP measurement can easily be integrated into clinical routine as it only requires a blood sample.

The goal of this prospective study is to determine whether changes in CRP levels in the blood can predict the disease progression or response to immunotherapy.

blood sample to assess laboratory parameters: Leukocytes, neutrophil granulocytes, lymphocytes, hemoglobin, hematocrit, thrombocytes, kreatinin, glomerular filtration rate (GFR), serum glutamic oxaloacetic transaminase (GOT), serum glutamic pyruvic transaminase (GPT), bilirubin, lactate dehydrogenase (LDH), thyroid stimulating hormone (TSH), fT3 (free tri-iodothyronine), fT4 (free thyroxine), amylase, CRP, biomarkers related to immune response

Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

Evaluation of CRP kinetics to predict progression-free survival in advanced or metastatic gynecological malignancies treated with ICIs in combination with chemotherapy. The CRP value is determined from blood samples.

* evaluation of CRP kinetics to predict objective response in patients with advanced or metastatic gynecological malignancies receiving ICIs in combination with chemotherapy
* evaluation of CRP kinetics to predict overall survival in patients with advanced or metastatic gynecological malignancies receiving ICI in combination with chemotherapy
* Exploratory analysis of further biomarkers related to immune response The respective values are determined from blood samples.

University Hospital Ulm

University Hospital Freiburg

University Hospital Tuebingen

Frozen sections taken from women operated on for possible gynecologic malignancies.

Mid-Infrared Spectroscopy with ATR

Ilan Bruchim, MD

The purpose of this study is to examine the efficacy of mid-infrared spectroscopy together with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in real time during surgery.

The Development of an In-vitro System to Identify Gynecologic Cancer Cells During Surgical Procedures

Results of Spectroscopy will be compared to frozen section/histopathology findings

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy	NCT06151028	Gynecological M... Menopausal Symp... Bone Loss	No intervention	18 Years - 55 Years	Anhui Provincial Hospital
An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy	NCT06151028	Gynecological M... Menopausal Symp... Bone Loss	No intervention	18 Years - 55 Years	Anhui Provincial Hospital
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies	NCT05990803	Cervical Cancer	BL-B01D1 SI-B003	18 Years - 75 Years	Sichuan Baili Pharmaceutical Co., Ltd.
A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations	NCT04905329	Solid Tumor High-Risk Cance... Breast Cancer Gastrointestina... Gynecological M... Myelosuppressio...	Empegfilgrastim	18 Years - 80 Years	Moscow Clinical Scientific Center
Influence of Gum Chewing on Postoperative Bowel Activity After Complete Staging Surgery for Gynecological Malignancies	NCT01835119	Postoperative I...	gum	-	Erzincan Military Hospital
Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy	NCT00121030	Gynecological M... Genital Neoplas... Anemia	darbepoetin alf... recombinant hum...	18 Years -	Amgen
Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies	NCT05914974	Gynecological M... Cervical Cancer Endometrial Can... Ovarian Cancer Vulvar Cancer		18 Years -	University Hospital Tuebingen
The Development of an In-vitro System to Identify Gynecologic Cancer Cells During Surgical Procedures	NCT02718209	Gynecological M...	Mid-Infrared Sp...	18 Years -	Hillel Yaffe Medical Center
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies	NCT05990803	Cervical Cancer	BL-B01D1 SI-B003	18 Years - 75 Years	Sichuan Baili Pharmaceutical Co., Ltd.
A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations	NCT04905329	Solid Tumor High-Risk Cance... Breast Cancer Gastrointestina... Gynecological M... Myelosuppressio...	Empegfilgrastim	18 Years - 80 Years	Moscow Clinical Scientific Center

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