ID

13806

Beschrijving

Monitoring Minimal Residual Disease Following Treatment of Patients With Acute Myeloid Leukemia (AML) or High Grade Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT01311258

Link

https://clinicaltrials.gov/show/NCT01311258

Trefwoorden

Versies (1)
  1. 07-03-16 07-03-16 -
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CC BY-NC 3.0

Geüploaded op

7 maart 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01311258

Engels

Eligibility Acute Myeloid Leukemia NCT01311258

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
are being evaluated for the diagnosis and/or treatment of acute myelogenous leukemia or high grade mds (defined as greater than 10 percent blasts on examination of the bone marrow aspirate).
Beschrijving

AML MDS

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
have not undergone prior cytotoxic therapy for aml or high grade mds in the past 3 months other than hydroxyurea or revlamid.
Beschrijving

prior therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0677881
UMLS CUI [2]
C0591617
have not previously received an allogeneic peripheral blood or bone marrow stem cell transplant for their disease.
Beschrijving

allogeneic peripheral blood or bone marrow stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1]
C1518999
UMLS CUI [2]
C0842093
are able to sign an informed consent. informed consent must be signed at the time of enrollment and prior to the collection of any specimens and/or clinical data (other than phi needed to screen and identify patients, which will be promptly discarded in a secure fashion if patient is not enrolled on study)
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
are at least 18 years of age.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
do not have any serious medical or psychiatric illness, other than that treated by this study which would limit the ability of the patient to receive therapy or give informed consent.
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
have been informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who are less than 18 years of age.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subjects with limited decision making capacity.
Beschrijving

subjects with limited decision making capacity.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
subjects who have received prior cytotoxic therapy, other than hydroxyurea or revlamid, for their disease within the past three months.
Beschrijving

prior cytotoxic therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0677881
UMLS CUI [2]
C0591617
patients with a diagnosis of cml in blast crisis, acute promyelocytic leukemia, or bi-lineage leukemia.
Beschrijving

cml in blast crisis, apl

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023473
UMLS CUI [1,2]
C0005699
UMLS CUI [2]
C0023487
UMLS CUI [3]
C4023020
subjects who have previously undergone an allogeneic peripheral blood stem cell transplant.
Beschrijving

allogenic blood stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242602
UMLS CUI [1,2]
C1515895
have an active malignancy other than aml or mds at the time of evaluation or a prior history of treatment for a malignancy other than aml or mds within the past 2 years.
Beschrijving

other malignancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0003392
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Similar models

Eligibility Acute Myeloid Leukemia NCT01311258

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
AML MDS
Item
are being evaluated for the diagnosis and/or treatment of acute myelogenous leukemia or high grade mds (defined as greater than 10 percent blasts on examination of the bone marrow aspirate).
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
prior therapy
Item
have not undergone prior cytotoxic therapy for aml or high grade mds in the past 3 months other than hydroxyurea or revlamid.
boolean
C1514463 (UMLS CUI [1,1])
C0677881 (UMLS CUI [1,2])
C0591617 (UMLS CUI [2])
allogeneic peripheral blood or bone marrow stem cell transplant
Item
have not previously received an allogeneic peripheral blood or bone marrow stem cell transplant for their disease.
boolean
C1518999 (UMLS CUI [1])
C0842093 (UMLS CUI [2])
informed consent
Item
are able to sign an informed consent. informed consent must be signed at the time of enrollment and prior to the collection of any specimens and/or clinical data (other than phi needed to screen and identify patients, which will be promptly discarded in a secure fashion if patient is not enrolled on study)
boolean
C0021430 (UMLS CUI [1])
age
Item
are at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
comorbidity
Item
do not have any serious medical or psychiatric illness, other than that treated by this study which would limit the ability of the patient to receive therapy or give informed consent.
boolean
C0009488 (UMLS CUI [1])
informed consent
Item
have been informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
age
Item
subjects who are less than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
subjects with limited decision making capacity.
Item
subjects with limited decision making capacity.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
prior cytotoxic therapy
Item
subjects who have received prior cytotoxic therapy, other than hydroxyurea or revlamid, for their disease within the past three months.
boolean
C1514463 (UMLS CUI [1,1])
C0677881 (UMLS CUI [1,2])
C0591617 (UMLS CUI [2])
cml in blast crisis, apl
Item
patients with a diagnosis of cml in blast crisis, acute promyelocytic leukemia, or bi-lineage leukemia.
boolean
C0023473 (UMLS CUI [1,1])
C0005699 (UMLS CUI [1,2])
C0023487 (UMLS CUI [2])
C4023020 (UMLS CUI [3])
allogenic blood stem cell transplant
Item
subjects who have previously undergone an allogeneic peripheral blood stem cell transplant.
boolean
C0242602 (UMLS CUI [1,1])
C1515895 (UMLS CUI [1,2])
other malignancy
Item
have an active malignancy other than aml or mds at the time of evaluation or a prior history of treatment for a malignancy other than aml or mds within the past 2 years.
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0003392 (UMLS CUI [2,2])
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