ID

35091

Beskrivning

Strain Echocardiography to Predict Cardiotoxicity in Patients Receiving Chemotherapy Containing Doxorubicin; ODM derived from: https://clinicaltrials.gov/show/NCT02423356

Länk

https://clinicaltrials.gov/show/NCT02423356

Nyckelord

Versioner (1)
  1. 2019-02-15 2019-02-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 februari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02423356

Engelsk

Eligibility Breast Neoplasms NCT02423356

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must be at least 18 years old at the time of informed consent
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients must be able to speak and read english.
Beskrivning

Able to speak English Language | Able to read English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
3. patients must be able to provide written informed consent and hipaa authorization
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
4. patients must have a current diagnosis of sarcoma, lymphoma, or her2(-) breast cancer
Beskrivning

Sarcoma | Lymphoma | Breast Carcinoma HER2 Negative

Datatyp

boolean

Alias
UMLS CUI [1]
C1261473
UMLS CUI [2]
C0024299
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C2348908
5. patients must be deemed appropriate for doxorubicin-based chemotherapy regardless of individual diagnosis or stage of disease.
Beskrivning

Doxorubicin | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0013089
UMLS CUI [2]
C0392920
6. patients must have planned treatment with doxorubicin:
Beskrivning

Doxorubicin Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C1301732
patients with sarcoma must have an initial planned regimen including 75 mg/m2 doxorubicin for at least 4 cycles. note: patients can be on additional chemotherapeutic agents.
Beskrivning

Sarcoma | Doxorubicin Dosage | Chemotherapy cycle Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C1261473
UMLS CUI [2,1]
C0013089
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C1265611
patients with lymphoma must have an initial planned regimen including 50 mg/m2of doxorubicin for at least 6 cycles. note: patients can be on additional chemotherapeutic agents.
Beskrivning

Lymphoma | Doxorubicin Dosage | Chemotherapy cycle Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0024299
UMLS CUI [2,1]
C0013089
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C1265611
patients with breast cancer must have an initial planned regimen including 60 mg/m2 of doxorubicin for at least 4 cycles. breast cancer patient enrollment will stop once 60 breast cancer patients have been enrolled.
Beskrivning

Breast Carcinoma | Doxorubicin Dosage | Chemotherapy cycle Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0013089
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C1265611
note: patients can be on additional chemotherapeutic agents.
Beskrivning

Antineoplastic Agents Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C1524062
7. patients must have their echocardiograms performed such that strain may be calculated using either ge or tomtec software.
Beskrivning

Echocardiography | Myocardial strain Calculation | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1]
C0013516
UMLS CUI [2,1]
C1868749
UMLS CUI [2,2]
C1441506
UMLS CUI [3]
C3846158
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinical history of heart failure or ejection fraction (ef) on initial exam is <53%.
Beskrivning

Heart failure | Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0232174
2. initial echocardiograms are not interpretable.
Beskrivning

Echocardiogram Interpretation Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2243117
UMLS CUI [1,2]
C0459471
UMLS CUI [1,3]
C1272705
3. wall motion abnormalities are present on initial echocardiograms.
Beskrivning

Wall motion Abnormality Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1980023
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0013516
4. strain on initial echocardiograms cannot be calculated.
Beskrivning

Echocardiography | Myocardial strain Calculation Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1]
C0013516
UMLS CUI [2,1]
C1868749
UMLS CUI [2,2]
C1441506
UMLS CUI [2,3]
C1272705
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Similar models

Eligibility Breast Neoplasms NCT02423356

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients must be at least 18 years old at the time of informed consent
boolean
C0001779 (UMLS CUI [1])
Able to speak English Language | Able to read English Language
Item
2. patients must be able to speak and read english.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Informed Consent
Item
3. patients must be able to provide written informed consent and hipaa authorization
boolean
C0021430 (UMLS CUI [1])
Sarcoma | Lymphoma | Breast Carcinoma HER2 Negative
Item
4. patients must have a current diagnosis of sarcoma, lymphoma, or her2(-) breast cancer
boolean
C1261473 (UMLS CUI [1])
C0024299 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C2348908 (UMLS CUI [3,2])
Doxorubicin | Chemotherapy
Item
5. patients must be deemed appropriate for doxorubicin-based chemotherapy regardless of individual diagnosis or stage of disease.
boolean
C0013089 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Doxorubicin Planned
Item
6. patients must have planned treatment with doxorubicin:
boolean
C0013089 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Sarcoma | Doxorubicin Dosage | Chemotherapy cycle Quantity
Item
patients with sarcoma must have an initial planned regimen including 75 mg/m2 doxorubicin for at least 4 cycles. note: patients can be on additional chemotherapeutic agents.
boolean
C1261473 (UMLS CUI [1])
C0013089 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1302181 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Lymphoma | Doxorubicin Dosage | Chemotherapy cycle Quantity
Item
patients with lymphoma must have an initial planned regimen including 50 mg/m2of doxorubicin for at least 6 cycles. note: patients can be on additional chemotherapeutic agents.
boolean
C0024299 (UMLS CUI [1])
C0013089 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1302181 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Breast Carcinoma | Doxorubicin Dosage | Chemotherapy cycle Quantity
Item
patients with breast cancer must have an initial planned regimen including 60 mg/m2 of doxorubicin for at least 4 cycles. breast cancer patient enrollment will stop once 60 breast cancer patients have been enrolled.
boolean
C0678222 (UMLS CUI [1])
C0013089 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1302181 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Antineoplastic Agents Additional
Item
note: patients can be on additional chemotherapeutic agents.
boolean
C0003392 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Echocardiography | Myocardial strain Calculation | Other Coding
Item
7. patients must have their echocardiograms performed such that strain may be calculated using either ge or tomtec software.
boolean
C0013516 (UMLS CUI [1])
C1868749 (UMLS CUI [2,1])
C1441506 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Heart failure | Cardiac ejection fraction
Item
1. clinical history of heart failure or ejection fraction (ef) on initial exam is <53%.
boolean
C0018801 (UMLS CUI [1])
C0232174 (UMLS CUI [2])
Echocardiogram Interpretation Unsuccessful
Item
2. initial echocardiograms are not interpretable.
boolean
C2243117 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Wall motion Abnormality Echocardiography
Item
3. wall motion abnormalities are present on initial echocardiograms.
boolean
C1980023 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
Echocardiography | Myocardial strain Calculation Unsuccessful
Item
4. strain on initial echocardiograms cannot be calculated.
boolean
C0013516 (UMLS CUI [1])
C1868749 (UMLS CUI [2,1])
C1441506 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
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