ID

24708

Beschrijving

Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00478985

Link

https://clinicaltrials.gov/show/NCT00478985

Trefwoorden

Versies (1)
  1. 14-08-17 14-08-17 -
Geüploaded op

14 augustus 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Myeloid Leukemia, Chronic NCT00478985

Engels

Eligibility Myeloid Leukemia, Chronic NCT00478985

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have reached their 18th birthday
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing potential must agree to use effective methods of contraception
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
patients must be affiliated to a social security regime
Beschrijving

Social Security Program Affiliated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037435
UMLS CUI [1,2]
C1510826
patients must have received imatinib therapy for at least 36 months.
Beschrijving

Imatinib

Datatype

boolean

Alias
UMLS CUI [1]
C0935989
patients must be in complete molecular remission during at least two consecutive years with at least five rt-pcr negative measures for bcr-abl transcripts.
Beschrijving

Molecular Complete Response | RT-PCR Measures Negative Quantity | BCR-ABL Transcript

Datatype

boolean

Alias
UMLS CUI [1]
C4050308
UMLS CUI [2,1]
C0599161
UMLS CUI [2,2]
C0079809
UMLS CUI [2,3]
C1513916
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C1835417
UMLS CUI [3,2]
C1519595
patients must be hiv, hcv and hbv negatives
Beschrijving

HIV negative | Hepatitis C test negative | Hepatitis B test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0481430
UMLS CUI [2]
C1619717
UMLS CUI [3]
C1611173
patients who have molecular follow-up realized in accordance with international recommendations
Beschrijving

Follow-up Molecular

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C1521991
all patients must be informed of the investigational nature of this study and must sign and give written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are protected by the law. patients who are unable to give their consent to participate to the study.
Beschrijving

Patients Protection Law | Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1545588
UMLS CUI [1,3]
C0220866
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping imatinib. patients who have pathologies or treatments which able to interfere with immunologic study (excepted ifn α):
Beschrijving

Imatinib Discontinued | Pathology At risk for relapse | Therapeutic procedure At risk for relapse | Pathology Interferes with Study immunologic | Therapeutic procedure Interferes with Study immunologic | Exception Interferon

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935989
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0677042
UMLS CUI [2,2]
C1320679
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1320679
UMLS CUI [4,1]
C0677042
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2603343
UMLS CUI [4,4]
C0205470
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2603343
UMLS CUI [5,4]
C0205470
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C3652465
corticosteroids or other immuno suppressors other concomitant malign pathology treated by chemotherapy or radiotherapy previous or programmed haematopoietic stem cell allogreffe
Beschrijving

Adrenal Cortex Hormones | Immunosuppressive Agents | Chemotherapy Malignant Neoplasms | Therapeutic radiology procedure Malignant Neoplasms | Hemopoietic stem cell transplantation | Hemopoietic stem cell transplantation Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0021081
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0006826
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0006826
UMLS CUI [5]
C0472699
UMLS CUI [6,1]
C0472699
UMLS CUI [6,2]
C1301732
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Similar models

Eligibility Myeloid Leukemia, Chronic NCT00478985

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients must have reached their 18th birthday
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must agree to use effective methods of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Social Security Program Affiliated
Item
patients must be affiliated to a social security regime
boolean
C0037435 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
Imatinib
Item
patients must have received imatinib therapy for at least 36 months.
boolean
C0935989 (UMLS CUI [1])
Molecular Complete Response | RT-PCR Measures Negative Quantity | BCR-ABL Transcript
Item
patients must be in complete molecular remission during at least two consecutive years with at least five rt-pcr negative measures for bcr-abl transcripts.
boolean
C4050308 (UMLS CUI [1])
C0599161 (UMLS CUI [2,1])
C0079809 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C1835417 (UMLS CUI [3,1])
C1519595 (UMLS CUI [3,2])
HIV negative | Hepatitis C test negative | Hepatitis B test negative
Item
patients must be hiv, hcv and hbv negatives
boolean
C0481430 (UMLS CUI [1])
C1619717 (UMLS CUI [2])
C1611173 (UMLS CUI [3])
Follow-up Molecular
Item
patients who have molecular follow-up realized in accordance with international recommendations
boolean
C1522577 (UMLS CUI [1,1])
C1521991 (UMLS CUI [1,2])
Informed Consent
Item
all patients must be informed of the investigational nature of this study and must sign and give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patients Protection Law | Informed Consent Unable
Item
patients who are protected by the law. patients who are unable to give their consent to participate to the study.
boolean
C0030705 (UMLS CUI [1,1])
C1545588 (UMLS CUI [1,2])
C0220866 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Imatinib Discontinued | Pathology At risk for relapse | Therapeutic procedure At risk for relapse | Pathology Interferes with Study immunologic | Therapeutic procedure Interferes with Study immunologic | Exception Interferon
Item
patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping imatinib. patients who have pathologies or treatments which able to interfere with immunologic study (excepted ifn α):
boolean
C0935989 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0677042 (UMLS CUI [2,1])
C1320679 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1320679 (UMLS CUI [3,2])
C0677042 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2603343 (UMLS CUI [4,3])
C0205470 (UMLS CUI [4,4])
C0087111 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2603343 (UMLS CUI [5,3])
C0205470 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C3652465 (UMLS CUI [6,2])
Adrenal Cortex Hormones | Immunosuppressive Agents | Chemotherapy Malignant Neoplasms | Therapeutic radiology procedure Malignant Neoplasms | Hemopoietic stem cell transplantation | Hemopoietic stem cell transplantation Planned
Item
corticosteroids or other immuno suppressors other concomitant malign pathology treated by chemotherapy or radiotherapy previous or programmed haematopoietic stem cell allogreffe
boolean
C0001617 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C0472699 (UMLS CUI [5])
C0472699 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
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