CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,007 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01813721
NCT01813721N/ACompleted

Study to Investigate Which Clinical Risk Factors Are Considered by Physicians When Conducting Overall Febrile Neutropenia Risk Assessments for Patients Receiving Chemotherapy With an Intermediate (10% - 20%) Febrile Neutropenia Risk.

Amgen·observational·Posted Mar 19, 2013·Updated Mar 15, 2017

In Brief

An observational study for Chemotherapy-induced Febrile Neutropenia. Completed, enrolled 1,007 participants across 90 sites in 11 countries.

Detailed Summary

This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Canada, France, Germany, Greece, Ireland, Italy, Poland, Romania, Spain
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 19, 2013
Enrollment StartDec 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.3 years ago