ID

30322

Beskrivning

An Observational Study on The Health Related Quality of Life in Patients With Chronic Lymphocytic Leukaemia; ODM derived from: https://clinicaltrials.gov/show/NCT01395615

Länk

https://clinicaltrials.gov/show/NCT01395615

Nyckelord

Versioner (1)
  1. 2018-05-29 2018-05-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphocytic Leukemia, Chronic NCT01395615

Engelsk

Eligibility Lymphocytic Leukemia, Chronic NCT01395615

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
patients with chronic lymphocytic leukaemia
Beskrivning

Chronic Lymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023434
patients receiving 1st line therapy
Beskrivning

First line treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C1708063
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
Beskrivning

Second line treatment | First line treatment Disease Response | Recurrent disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1710038
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C1704632
UMLS CUI [3]
C0277556
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
Beskrivning

Therapeutic procedure Discontinued | Status post First line treatment Course Quantity | Status post Second line treatment Course Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C0750729
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1710038
UMLS CUI [3,3]
C0750729
UMLS CUI [3,4]
C1265611
patients receiving their 3rd, 4th, 5th or 6th cycle of 1st or 2nd line therapy
Beskrivning

First line treatment Course Ordinal number | Second line treatment Course Ordinal number

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C0439080
UMLS CUI [2,1]
C1710038
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C0439080
patients who have completed therapy, are considered stable and are between 3-12 months post therapy
Beskrivning

Treatment completed | Patient's condition stable | Status post Therapeutic procedure Month Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0580352
UMLS CUI [2]
C1282982
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0439231
UMLS CUI [3,4]
C1265611
eastern cooperative oncology group (ecog) performance status 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Beskrivning

Disease Clinical Significance | Exception Chronic Lymphocytic Leukemia | Exception Comorbidity lymphocytic chronic | Condition Interferes with Study Subject Participation Status | Condition Affecting Research results | Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023434
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0009488
UMLS CUI [3,3]
C2939172
UMLS CUI [3,4]
C0205191
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0683954
UMLS CUI [6]
C0038586
mental disability or significant mental illness, legal incapacity or limited legal capacity
Beskrivning

Mental handicap | Mental disorders | Legal capacity Lacking | Legal capacity Limited

Datatyp

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2]
C0004936
UMLS CUI [3,1]
C0683673
UMLS CUI [3,2]
C0332268
UMLS CUI [4,1]
C0683673
UMLS CUI [4,2]
C0439801
current high degree of comorbid burden that might affect the accuracy of the quality of life data
Beskrivning

Comorbidity Severe Affecting Quality of life

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0034380
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Similar models

Eligibility Lymphocytic Leukemia, Chronic NCT01395615

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Lymphocytic Leukemia
Item
patients with chronic lymphocytic leukaemia
boolean
C0023434 (UMLS CUI [1])
First line treatment
Item
patients receiving 1st line therapy
boolean
C1708063 (UMLS CUI [1])
Second line treatment | First line treatment Disease Response | Recurrent disease
Item
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
boolean
C1710038 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3])
Therapeutic procedure Discontinued | Status post First line treatment Course Quantity | Status post Second line treatment Course Quantity
Item
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
boolean
C0087111 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0750729 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0231290 (UMLS CUI [3,1])
C1710038 (UMLS CUI [3,2])
C0750729 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
First line treatment Course Ordinal number | Second line treatment Course Ordinal number
Item
patients receiving their 3rd, 4th, 5th or 6th cycle of 1st or 2nd line therapy
boolean
C1708063 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0439080 (UMLS CUI [1,3])
C1710038 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C0439080 (UMLS CUI [2,3])
Treatment completed | Patient's condition stable | Status post Therapeutic procedure Month Quantity
Item
patients who have completed therapy, are considered stable and are between 3-12 months post therapy
boolean
C0580352 (UMLS CUI [1])
C1282982 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0439231 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Clinical Significance | Exception Chronic Lymphocytic Leukemia | Exception Comorbidity lymphocytic chronic | Condition Interferes with Study Subject Participation Status | Condition Affecting Research results | Substance Use Disorders
Item
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
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
C2939172 (UMLS CUI [3,3])
C0205191 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0683954 (UMLS CUI [5,3])
C0038586 (UMLS CUI [6])
Mental handicap | Mental disorders | Legal capacity Lacking | Legal capacity Limited
Item
mental disability or significant mental illness, legal incapacity or limited legal capacity
boolean
C1306341 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0683673 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0683673 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
Comorbidity Severe Affecting Quality of life
Item
current high degree of comorbid burden that might affect the accuracy of the quality of life data
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0034380 (UMLS CUI [1,4])
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