ID

13806

Description

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

Keywords

Versions (1)
  1. 3/7/16 3/7/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 7, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Acute Myeloid Leukemia NCT01311258

English

Eligibility Acute Myeloid Leukemia NCT01311258

1 forms  
Inclusion Criteria
Description

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).
Description

AML MDS

Data type

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.
Description

prior therapy

Data type

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.
Description

allogeneic peripheral blood or bone marrow stem cell transplant

Data type

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)
Description

informed consent

Data type

boolean

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

age

Data type

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.
Description

comorbidity

Data type

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.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

age

Data type

boolean

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

subjects with limited decision making capacity.

Data type

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.
Description

prior cytotoxic therapy

Data type

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.
Description

cml in blast crisis, apl

Data type

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.
Description

allogenic blood stem cell transplant

Data type

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.
Description

other malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0003392
Back to the top of the page

Similar models

Eligibility Acute Myeloid Leukemia NCT01311258

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial