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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01395615 |
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Date of registration:
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14/07/2011 |
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Primary sponsor: |
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Public title:
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An Observational Study on The Health Related Quality of Life in Patients With Chronic Lymphocytic Leukaemia
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Scientific title:
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Utility Measurement Study for Patients With Chronic Lymphocytic Leukaemia |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01395615 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Patients with chronic lymphocytic leukaemia
- Patients receiving 1st line therapy
- Patients receiving 2nd line therapy. This will include patients who previously have
responded well to 1st line therapy (relapse was >12 months after finishing the 1st
line therapy) and are receiving the same therapy again
- Within the past three months, patients whose treatment has been stopped after 2-3
cycles of 1st or 2nd line therapy and who have not received any further therapies
- Patients receiving their 3rd, 4th, 5th or 6th cycle of 1st or 2nd line therapy
- Patients who have completed therapy, are considered stable and are between 3-12
months post therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria:
- Clinically significant disorder (other than chronic lymphocytic leukaemia and chronic
lymphocytic comorbidities) or any other condition, including alcohol or drug abuse,
which may interfere with study participation or affect study conclusions
- Mental disability or significant mental illness, legal incapacity or limited legal
capacity
- Current high degree of comorbid burden that might affect the accuracy of the quality
of life data
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lymphocytic Leukemia, Chronic
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Primary Outcome(s)
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Quality of life: EORTC QLQ-CLL16 (chronic lymphocytic leukaemia) questionnaire
[Time Frame: 18 months]
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Quality of life: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
[Time Frame: 18 months]
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Quality of life: EuroQol Group EQ-5D questionnaire
[Time Frame: 18 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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