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Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment


N/A
18 Years
N/A
Not Enrolling
Both
Anemia, Neoplasms

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Trial Information

Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment


Inclusion Criteria:



- Adult patients, >/=18 years of age

- Patients receiving myelosuppressive chemotherapy for a solid tumor, a hematological
malignancy or an autograft for hematological malignancy

- Patients for whom treatment with epoetin beta is started at the inclusion visit

- Life expectancy >/=6 months according to the physician

- Patients accepting and able to complete a French written questionnaire about his/her
professional and social activities at each visit

Exclusion Criteria:

- Patients who received erythropoiesis-stimulating agents treatment, or red blood cell
transfusion within 4 weeks before enrollment

- Participation in a clinical trial in onco-hematology

- Patients with myelodysplasia

- Patients with more than one active malignancy at the time of enrollment

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To evaluate in daily routine practice the clinical benefit (i.e. transfusion avoidance, maintenance of general health status, professional and social activity) of NeoRecormon in anemic cancer patients, according to early response to treatment

Outcome Time Frame:

28 weeks

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ML22733

NCT ID:

NCT01168349

Start Date:

January 2010

Completion Date:

December 2010

Related Keywords:

  • Anemia, Neoplasms
  • Anemia
  • Neoplasms

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