Trial record 7 of 74 for:    "Kidney Neoplasms" AND (woman OR women OR female)

Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01444456
First received: September 29, 2011
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

This is a multicenter, international, prospective, observational study of subjects who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other ESA to treat symptomatic anaemia.

Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those subjects receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of >=1 g/dL


Condition
Anemia
Breast Cancer
Cancer
Colorectal Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Solid Tumors
Bladder Cancer
Endometrial Cancer
Renal Cancer
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electronic Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia: An International Prospective Observational Study (eAQUA)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Proportion of subjects receiving darbepoetin alfa with improvement in Patient Perceived Fatigue (PPF) and increase in Hb >=1 g/dL [ Time Frame: From Baseline to Week 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects by tumour type with improvement in Patient Perceived Fatigue (PPF) and increase in Hb >=1 g/dL [ Time Frame: From Baseline to Week 9 ] [ Designated as safety issue: No ]

Enrollment: 1264
Study Start Date: September 2011
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients taking Aranesp
Patients taking any ESA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adults with either breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric cancer who will receive darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) for the treatment of symptomatic chemotherapy-induced anaemia (CIA) in routine clinical practice

Criteria

Inclusion Criteria:

  • Diagnosed with breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric cancer
  • Expected to receive at least 8 additional weeks of a given regimen of myelosuppressive chemotherapy after enrolment
  • Starting treatment with either darbepoetin alfa (in Cohort 1 countries) or any ESA (in Cohort 2 countries) as per European Summary of Product Characteristics (SPC) for symptomatic anaemia.

Exclusion Criteria:

  • Received any ESA treatment or Red Blood Cell (RBC) transfusion within 28 days prior to enrolment
  • Known primary benign or malignant haematologic disorder which can cause anaemia
  • Known hypersensitivity to ESAs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444456

  Show 118 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01444456     History of Changes
Other Study ID Numbers: 20101123
Study First Received: September 29, 2011
Last Updated: April 30, 2014
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen
Austria: Central Ethics Committee
Belgium: Ethisch committee Imelda ziekenhuis Bonheiden
Germany: Central associations of the statutory health insurance funds
Germany: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Panel Doctors' Association
Italy: Comitato Etico della Fondazione Istituto San Raffaele-G.Giglio di Cefalù
Netherlands: METOPP (Medisch-Ethische Toetsing Onderzoek Patiënten en Proefpersonen)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority
Romania: Ministry of Public Health

Keywords provided by Amgen:
Renal Cancer
Breast Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Colorectal Cancer
Aranesp
Chemotherapy induced anaemia
Chemotherapy
Bladder Cancer
Endometrial Cancer
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Genital Neoplasms, Female
Genital Diseases, Female
Anemia
Urinary Bladder Neoplasms
Breast Neoplasms
Endometrial Neoplasms
Carcinoma, Renal Cell
Colorectal Neoplasms
Esophageal Neoplasms
Lung Neoplasms
Stomach Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Prostatic Neoplasms
Hematologic Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Breast Diseases
Skin Diseases
Uterine Neoplasms
Uterine Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 22, 2014