Blood and Lymph Conditions

All Conditions

Rare Diseases

Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Mecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle,

24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle

Mecapegfilgrastim Injection

Lingfang Xia, M.D.

Xiaohua Wu, MD&PHD

Xiaohua Wu

This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy.

Patients are randomized into study group and control group. All patients receive PTX+platinum chemotherapy of 3 weeks. In study group, patients accept PEG-rhG-CSF 24-48 hours from the chemotherapy. While the control group patients are only observed closely. Patient receive three courses of treatment.

The primary end is the incidence of 3/4 level neutropenia in three courses of chemotherapy.

The secondary ends include: the incidences and duration of neutropenia in every course of chemotherapy, the incidences of FN in three courses and every course of chemotherapy, the incidences of infection in three courses and every course of chemotherapy, the delay time of the next cycle of chemotherapy due to FN or infection, the RDI of the second and third cycles of chemotherapy, adverse events related to G-CSF, quality of life, cost of medicine and admitting.

Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies

A Multicenter, Randomized Controlled, Open Clinical Study of the Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemotherapy in Patients With Gynecological Malignancies

data is available per require after approved by ethics broad

Incidence of third/fourth level neutropenia during three cycles chemotherapy

Incidence of febrile neutropenia during every cycle chemotherapy

The duration time of third/fourth level neutropenia during three cycles chemotherapy

The delay time of the next cycle of chemotherapy due to FN or infection

Relative dose intensity of the second and third chemotherapy

Incidence of adverse events related to granulocyte colony stimulating factor according to common Terminology Criteria for Adverse Events (CTCAE) v5.0

Xiaohua Wu MD

director of gynecologic oncology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Uterine Cervical Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

patients with cervical cancer, endometrial cancers or ovary cancer

As human aging, 50% of women will be faced with the threat of cancer, especially gynecological malignancies. Ovarian, cervical and endometrial cancer are three major gynecological malignancies. In recent years, the incidence of cervical cancer, especially in young women significantly increased; ovarian cancer, although the incidence of malignant tumors in the female reproductive system ranked second, but its mortality rate already in the first place; and the morbidity and mortality of endometrial cancer is also rising.

The key to gynecologic malignancies is how to early diagnose and treat. With the advancement of science and technology, such as molecular biology techniques widely used in the medical field, early diagnosis, proper treatment and other aspects in gynecologic malignancies is expected to achieve a breakthrough. Genome-wide scan strategy, making the whole genome for linkage analysis for gynecological malignancies possible. Therefore, the investigators intend to find specific mutations to provide a new early screening approach for gynecological malignancies, which in later result in early diagnosis and specific treatment for gynecological malignant tumors.

The sample of blood, urine, cervical exfoliated cells and cancer tissue of patient should be used only in this research with informed consent. The remaining part will be Safekeeping.All information is strictly confidential.

The Study of Massively Parallel Sequencing in Early Detection for Gynecologic Malignant Tumor

We expect to found spcific DNA mutation in the species (peripheral blood, liquid Pap smear and cancer tissue) from cervical cancer, endometrial cancers and ovary.

Comparing sensiitivity of the three kinds of samples on early detection of gynecologic malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies	NCT04773327	Gynecologic Mal...	Mecapegfilgrast...	18 Years - 70 Years	Fudan University
Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies	NCT04773327	Gynecologic Mal...	Mecapegfilgrast...	18 Years - 70 Years	Fudan University
The Study of Massively Parallel Sequencing in Early Detection for Gynecologic Malignant Tumor	NCT02166515	Gynecologic Mal...		16 Years - 75 Years	Third Military Medical University

Spots Global Cancer Trial Database for gynecologic malignant tumor