Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study

NCT02454530

Last updated date
Study Location
Clinique Rambot La Provençale Tour d'Aygosi
Aix En Provence, , 13100, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chemotherapy-Induced Neutropenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour.

- Patients for whom the oncologist has decided the initiation of G-CSF biosimilar treatment (Nivestim®) in primary or secondary prophylaxis.

- Patients informed about the computer processing of their medical data and their right of access and correction.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients with contraindication of use of Nivestim®.


- Patients with haematological malignancy including Myelodysplasia and Chronic myeloid
leukemia treated or untreated.


- Patients participating or having participated in the previous month in a clinical
trial.


- Patients refusing to participate in this study.

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Chemotherapy-Induced NeutropeniaUse of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
NCT02454530
  1. Aix En Provence,
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  4. Angers,
  5. Armentieres,
  6. Arras Cedex,
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  22. Caen Cedex 5,
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  28. Cherbourg,
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  55. Marseille,
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  60. Montpellier Cedex 5,
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  64. Nancy,
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  69. Paris Cedex 18,
  70. Paris Cedex 20,
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  81. Rouen,
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  86. Soyaux,
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  89. Thionville,
  90. Toulouse Cedex 3,
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  92. Tours Cedex 9,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
Official Title PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.
Brief Summary The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with solid tumour treated with cytotoxic chemotherapy and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) is initiated
Condition Chemotherapy-Induced Neutropenia
Intervention Biological: Nivestim®
Study Groups/Cohorts Cancer patients treated with Nivestim®
Intervention: Biological: Nivestim®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 29, 2019)
1160
Original Estimated Enrollment
 (submitted: May 26, 2015)
1200
Actual Study Completion Date January 2017
Actual Primary Completion Date October 18, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour.
  • Patients for whom the oncologist has decided the initiation of G-CSF biosimilar treatment (Nivestim®) in primary or secondary prophylaxis.
  • Patients informed about the computer processing of their medical data and their right of access and correction.

Exclusion Criteria:

  • Patients with contraindication of use of Nivestim®.
  • Patients with haematological malignancy including Myelodysplasia and Chronic myeloid leukemia treated or untreated.
  • Patients participating or having participated in the previous month in a clinical trial.
  • Patients refusing to participate in this study.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02454530
Other Study ID Numbers VISTA
C1121007 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2019