ID

17910

Description

Vitalis Study - Observational Study on the Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia (B-CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00344825

Link

https://clinicaltrials.gov/show/NCT00344825

Keywords

  1. 10/7/16 10/7/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

October 7, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Leukemia, B-Cell, Chronic NCT00344825

Eligibility Leukemia, B-Cell, Chronic NCT00344825

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged >/=18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients of either sex with b-cll, who are starting a new pharmacological treatment for b-chronic lymphocytic leukemia (1st, 2nd, 3rd, 4th)
Description

Gender | Chronic Lymphocytic Leukemia | Pharmacotherapy New Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0023434
UMLS CUI [3,1]
C0013216
UMLS CUI [3,2]
C0205314
UMLS CUI [3,3]
C0023434
foreseen duration of cll therapy </= 6 months
Description

Duration of therapy Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0444917
UMLS CUI [1,2]
C0023434
b-chronic lymphocytic leukemia progressive stage a, stage b or c (according to binet system), or ii-iv (according to rai system)
Description

Chronic Lymphocytic Leukemia | Binet Staging System | Rai Staging System

Data type

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C1511118
UMLS CUI [3]
C1514715
who performance status </= 2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
life expectancy </= 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
signed informed consent for personal data's treatment and availability to fill in the qol questionnaire
Description

Informed Consent | Quality of life scale

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0451401
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with any other tumour disease
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
chronic lymphocytic leukemia therapy in the last 30 days before v0
Description

Therapeutic procedure Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0023434
more than 3 previous cll treatments (the therapy is defined by the drug and/or the treatment period)
Description

Therapeutic procedure Quantity Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023434
previous stem cells transplantation
Description

Stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C1504389
concurrent or in the last 30 days participation to any other clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
any medical or psychological conditions that might compromise the capacity to sign the consent for personal data's treatment or to fill in the qol questionnaire
Description

medical condition Informed Consent Limited | medical condition Affecting Completion Quality of life scale | Mental condition Informed Consent Limited | Mental condition Affecting Completion Quality of life scale

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C0451401
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0021430
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0205197
UMLS CUI [4,4]
C0451401

Similar models

Eligibility Leukemia, B-Cell, Chronic NCT00344825

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged >/=18 years
boolean
C0001779 (UMLS CUI [1])
Gender | Chronic Lymphocytic Leukemia | Pharmacotherapy New Chronic Lymphocytic Leukemia
Item
patients of either sex with b-cll, who are starting a new pharmacological treatment for b-chronic lymphocytic leukemia (1st, 2nd, 3rd, 4th)
boolean
C0079399 (UMLS CUI [1])
C0023434 (UMLS CUI [2])
C0013216 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C0023434 (UMLS CUI [3,3])
Duration of therapy Chronic Lymphocytic Leukemia
Item
foreseen duration of cll therapy </= 6 months
boolean
C0444917 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Chronic Lymphocytic Leukemia | Binet Staging System | Rai Staging System
Item
b-chronic lymphocytic leukemia progressive stage a, stage b or c (according to binet system), or ii-iv (according to rai system)
boolean
C0023434 (UMLS CUI [1])
C1511118 (UMLS CUI [2])
C1514715 (UMLS CUI [3])
WHO performance status scale
Item
who performance status </= 2
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
life expectancy </= 6 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent | Quality of life scale
Item
signed informed consent for personal data's treatment and availability to fill in the qol questionnaire
boolean
C0021430 (UMLS CUI [1])
C0451401 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms
Item
patients with any other tumour disease
boolean
C0006826 (UMLS CUI [1])
Therapeutic procedure Chronic Lymphocytic Leukemia
Item
chronic lymphocytic leukemia therapy in the last 30 days before v0
boolean
C0087111 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Therapeutic procedure Quantity Chronic Lymphocytic Leukemia
Item
more than 3 previous cll treatments (the therapy is defined by the drug and/or the treatment period)
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
Stem cell transplant
Item
previous stem cells transplantation
boolean
C1504389 (UMLS CUI [1])
Study Subject Participation Status
Item
concurrent or in the last 30 days participation to any other clinical trial
boolean
C2348568 (UMLS CUI [1])
medical condition Informed Consent Limited | medical condition Affecting Completion Quality of life scale | Mental condition Informed Consent Limited | Mental condition Affecting Completion Quality of life scale
Item
any medical or psychological conditions that might compromise the capacity to sign the consent for personal data's treatment or to fill in the qol questionnaire
boolean
C3843040 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0451401 (UMLS CUI [2,4])
C3840291 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
C0451401 (UMLS CUI [4,4])

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