Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study (VISTA)
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|ClinicalTrials.gov Identifier: NCT02454530|
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment|
|Chemotherapy-Induced Neutropenia||Biological: Nivestim®|
This is a longitudinal, observational, prospective, multicentre, cohort study, conducted in France among a representative sample of public and/or private hospital-based oncologists.
Data will be collected by the investigator during three visits using data available in the patient medical record and obtained from patient questioning and clinical examination performed during the consultations:
- Baseline visit: prescription of Nivestim®.
- Follow-up visit: during the first cycle of chemotherapy after the first course of Nivestim®.
- Final visit: after the last cycle of chemotherapy or 16-18 weeks after inclusion.
|Study Type :||Observational|
|Actual Enrollment :||1154 participants|
|Official Title:||Prophylactic Treatment For Chemo-induced Neutropenia. Use Of G-csf Biosimilar (Nivestim(Registered)) According To The Chemotherapy Context: Adjuvant Versus Metastatic.|
|Actual Study Start Date :||September 2014|
|Primary Completion Date :||October 18, 2016|
|Study Completion Date :||February 2017|
|Cancer patients treated with Nivestim®||Biological: Nivestim®|
- Patterns of use of prophylactic Nivestim® for chemo-induced neutropenia [ Time Frame: End of the baseline visit (Patients are included at the time of the Nivestim® prescription prior to their chemotherapy) ]The patterns of use of Nivestim® will be described, globally and by subgroups (adjuvant and metastatic setting). It will be assessed from the profile of patients (infectious history, stage of the disease ...) and the oncologist motivations at initiation of prophylactic Nivestim® treatment
- Tolerance to treatment with Nivestim® [ Time Frame: Each patient will be followed up to maximum 16-18 weeks after baseline visit or after the last cycle of chemotherapy ]The safety will be assessed by the record of adverse effects (serious or not) and treatment discontinuation.
- Profile of patients under Nivestim® treatment [ Time Frame: End of baseline visit ]Patients' profiles treated with Nivestim® will be described from the questionnaire completed by the investigator during the baseline visit.
- Chemotherapy variations in terms of dose intensity and duration of cycles [ Time Frame: End of follow-up visit and final visit (maximum 16-18 weeks after baseline visit or after the last cycle of chemotherapy) ]Chemotherapy variations (scheduled or unscheduled discontinuation; occurrence of neutropenia; occurrence of infection; any protocol amendment; prophylaxis with Nivestim®) will be described from the questionnaire completed by the investigator during the follow-up and final visits.
- Incidence of neutropenia and febrile neutropenia [ Time Frame: End of follow-up visit and final visit (maximum 16-18 weeks after baseline visit or after the last cycle of chemotherapy) ]The incidence of neutropenia and febrile neutropenia will be described from the questionnaire completed by the investigator during the follow-up and final visits.
- Experience of patients treated with Nivestim® [ Time Frame: End of final visit (maximum 16-18 weeks after baseline visit or after the last cycle of chemotherapy) ]Patients' experience treated with Nivestim® after the chemotherapy will be described from the questionnaire completed by the investigator during the final visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454530
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|