Spots Global Cancer Trial Database for A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations
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Trial Identification
Brief Title: A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations
Official Title: 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
Study ID: NCT04905329
Interventions
Study Description
Brief Summary: 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
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moscow Clinical Scientific Center named after AS Loginov, Moscow, Not Required, Russian Federation
FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia, Moscow, Not Required, Russian Federation
FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation, Moscow, , Russian Federation
Contact Details
Name: Inna Ganshina, MD, PhD
Affiliation: FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
Role: PRINCIPAL_INVESTIGATOR
Name: Lyudmila Zhukova, MD, PhD, professor
Affiliation: Moscow Clinical Scientific Center named after AS Loginov
Role: STUDY_CHAIR
Name: Alexey Tryakin, MD, PhD, professor
Affiliation: FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
Role: PRINCIPAL_INVESTIGATOR
Name: Mikhail Fedyanin, MD, PhD, professor
Affiliation: FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
Role: PRINCIPAL_INVESTIGATOR
Name: Svetlana Khokhlova, MD, PhD
Affiliation: FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation
Role: PRINCIPAL_INVESTIGATOR
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