ID

38200

Beschreibung

Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification; ODM derived from: https://clinicaltrials.gov/show/NCT02177175

Link

https://clinicaltrials.gov/show/NCT02177175

Stichworte

Versionen (2)
  1. 26.09.19 26.09.19 -
  2. 26.09.19 26.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

26. September 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT02177175

Englisch

Eligibility Breast Cancer NCT02177175

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
age ≥ 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
non-metastatic histologically confirmed primary invasive breast carcinoma
Beschreibung

Invasive carcinoma of breast | Neoplasm Metastasis Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
pathologically confirmed her2-positive breast cancer
Beschreibung

HER2-positive carcinoma of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C1960398
scheduled to receive anthracycline chemotherapy followed by anti-her2 therapy at mskcc
Beschreibung

Chemotherapy Scheduled | Anthracyclines | HER2 Targeted Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205539
UMLS CUI [2]
C0282564
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C2985566
able and willing to provide informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
willing and able to comply with the requirements of the protocol
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
able to swallow capsules
Beschreibung

Able to swallow capsules

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
for aim 2, all patients must meet the following criteria:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
meet all inclusion criteria above
Beschreibung

Inclusion criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
lvef > 50%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
abnormal global longitudinal strain (<19%, or a % decrease of ≥ 11% from baseline) prior to initiation of planned anti-her2 therapy
Beschreibung

Longitudinal strain rate.diastole.max Abnormal | Longitudinal strain rate.systole.max Abnormal | Status pre- HER2 Targeted Therapy Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4263402
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C4263410
UMLS CUI [2,2]
C0205161
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0069515
UMLS CUI [3,3]
C2985566
UMLS CUI [3,4]
C1301732
heart rate ≥ 50 beats per minute
Beschreibung

Heart rate

Datentyp

boolean

Alias
UMLS CUI [1]
C0018810
sitting systolic blood pressure > 90 mmhg
Beschreibung

Sitting systolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C1319893
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients are to be excluded from randomization for aim 2 of this study if they meet any of the following criteria:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
current treatment with ace-inhibitors or beta blockers
Beschreibung

Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-1 Receptor Antagonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0304516
allergies or inability to tolerate beta blockers previously due to bradycardia, hypotension, or av block.
Beschreibung

Beta-blocker allergy | Adrenergic beta-1 Receptor Antagonists Receive Unable | Etiology Bradycardia | Etiology Hypotension | Etiology Atrioventricular Block

Datentyp

boolean

Alias
UMLS CUI [1]
C0570882
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0428977
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0020649
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0004245
known history of nci ctcae (version 4.0) grade ≥ 2 symptomatic chf, myocardial infarction within 12 months prior to randomization, significant symptoms (grade ≥ 3) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (grade ≥ 3)
Beschreibung

Symptomatic congestive heart failure CTCAE Grades | Myocardial Infarction | Symptoms CTCAE Grades | Relationship Left Ventricular Dysfunction | Valvular disease Moderate | Valvular disease Severe | Cardiac Arrhythmia CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0742758
UMLS CUI [1,2]
C1516728
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C1516728
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0242698
UMLS CUI [5,1]
C3258293
UMLS CUI [5,2]
C0205081
UMLS CUI [6,1]
C3258293
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C1516728
pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks of starting treatment
Beschreibung

Premenopausal state Serum pregnancy test negative Absent | Premenopausal state Urine pregnancy test negative Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0430061
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0430057
UMLS CUI [2,3]
C0332197
already enrolled in a breast cancer medicine therapeutic intervention trial
Beschreibung

Study Subject Participation Status | Clinical Trial Breast Carcinoma Interventional procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0184661
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT02177175

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Invasive carcinoma of breast | Neoplasm Metastasis Absent
Item
non-metastatic histologically confirmed primary invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
HER2-positive carcinoma of breast
Item
pathologically confirmed her2-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
Chemotherapy Scheduled | Anthracyclines | HER2 Targeted Therapy
Item
scheduled to receive anthracycline chemotherapy followed by anti-her2 therapy at mskcc
boolean
C0392920 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
C0069515 (UMLS CUI [3,1])
C2985566 (UMLS CUI [3,2])
Informed Consent
Item
able and willing to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with the requirements of the protocol
boolean
C0525058 (UMLS CUI [1])
Able to swallow capsules
Item
able to swallow capsules
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Criteria Fulfill
Item
for aim 2, all patients must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Inclusion criteria Fulfill
Item
meet all inclusion criteria above
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
lvef > 50%
boolean
C0428772 (UMLS CUI [1])
Longitudinal strain rate.diastole.max Abnormal | Longitudinal strain rate.systole.max Abnormal | Status pre- HER2 Targeted Therapy Planned
Item
abnormal global longitudinal strain (<19%, or a % decrease of ≥ 11% from baseline) prior to initiation of planned anti-her2 therapy
boolean
C4263402 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C4263410 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0069515 (UMLS CUI [3,2])
C2985566 (UMLS CUI [3,3])
C1301732 (UMLS CUI [3,4])
Heart rate
Item
heart rate ≥ 50 beats per minute
boolean
C0018810 (UMLS CUI [1])
Sitting systolic blood pressure
Item
sitting systolic blood pressure > 90 mmhg
boolean
C1319893 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients are to be excluded from randomization for aim 2 of this study if they meet any of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-1 Receptor Antagonists
Item
current treatment with ace-inhibitors or beta blockers
boolean
C0003015 (UMLS CUI [1])
C0304516 (UMLS CUI [2])
Beta-blocker allergy | Adrenergic beta-1 Receptor Antagonists Receive Unable | Etiology Bradycardia | Etiology Hypotension | Etiology Atrioventricular Block
Item
allergies or inability to tolerate beta blockers previously due to bradycardia, hypotension, or av block.
boolean
C0570882 (UMLS CUI [1])
C0304516 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0428977 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0020649 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0004245 (UMLS CUI [5,2])
Symptomatic congestive heart failure CTCAE Grades | Myocardial Infarction | Symptoms CTCAE Grades | Relationship Left Ventricular Dysfunction | Valvular disease Moderate | Valvular disease Severe | Cardiac Arrhythmia CTCAE Grades
Item
known history of nci ctcae (version 4.0) grade ≥ 2 symptomatic chf, myocardial infarction within 12 months prior to randomization, significant symptoms (grade ≥ 3) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (grade ≥ 3)
boolean
C0742758 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C0242698 (UMLS CUI [4,2])
C3258293 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
C3258293 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0003811 (UMLS CUI [7,1])
C1516728 (UMLS CUI [7,2])
Premenopausal state Serum pregnancy test negative Absent | Premenopausal state Urine pregnancy test negative Absent
Item
pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks of starting treatment
boolean
C0232969 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232969 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Study Subject Participation Status | Clinical Trial Breast Carcinoma Interventional procedure
Item
already enrolled in a breast cancer medicine therapeutic intervention trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video