ID

35102

Beschreibung

Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT02485626

Link

https://clinicaltrials.gov/show/NCT02485626

Stichworte

Versionen (1)
  1. 17.02.19 17.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

17. Februar 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02485626

Englisch

Eligibility Breast Neoplasms NCT02485626

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
early invasive bc (tnm stage i - iii);
Beschreibung

Invasive carcinoma of breast Early TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1279919
UMLS CUI [1,3]
C0474926
diagnosed and/or treated in the avl or umcg;
Beschreibung

Diagnosis Study Site | Therapeutic procedure Study Site

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C2825164
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2825164
treated 5 - 7 years or 10 - 12 years ago;
Beschreibung

Prior Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
aged 40-50 years at time of therapy;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
signed written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of rt or ct unrelated to bc;
Beschreibung

Prior radiation therapy Independent of Breast Carcinoma | CT Independent of Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0040405
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0678222
current treatment for bc recurrence or second malignancy (including contralateral bc) with the exception of non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix;
Beschreibung

Therapeutic procedure Breast cancer recurrent | Second Cancer | Contralateral breast cancer | Exception Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0278493
UMLS CUI [2]
C0751623
UMLS CUI [3]
C1096616
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0851140
history of cardiac disease (chf, acute coronary syndrome, coronary revascularization procedure, symptomatic valvular dysfunction, cardiomyopathy or congenital heart defect) before diagnosis and treatment for bc;
Beschreibung

Heart Disease | Congestive heart failure | Acute Coronary Syndrome | Coronary revascularisation | Dysfunction Heart Valve Symptomatic | Cardiomyopathy | Congenital Heart Defects

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0948089
UMLS CUI [4]
C0877341
UMLS CUI [5,1]
C3887504
UMLS CUI [5,2]
C0018826
UMLS CUI [5,3]
C0231220
UMLS CUI [6]
C0878544
UMLS CUI [7]
C0018798
mental disability or psychological condition potentially hampering compliance with the study protocol;
Beschreibung

Mental handicap Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
insufficient understanding of the dutch language.
Beschreibung

Comprehension Dutch Language Insufficient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376241
UMLS CUI [1,3]
C0231180
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Ähnliche Modelle

Eligibility Breast Neoplasms NCT02485626

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Early TNM Breast tumor staging
Item
early invasive bc (tnm stage i - iii);
boolean
C0853879 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Diagnosis Study Site | Therapeutic procedure Study Site
Item
diagnosed and/or treated in the avl or umcg;
boolean
C0011900 (UMLS CUI [1,1])
C2825164 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C2825164 (UMLS CUI [2,2])
Prior Therapy
Item
treated 5 - 7 years or 10 - 12 years ago;
boolean
C1514463 (UMLS CUI [1])
Age
Item
aged 40-50 years at time of therapy;
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior radiation therapy Independent of Breast Carcinoma | CT Independent of Breast Carcinoma
Item
history of rt or ct unrelated to bc;
boolean
C0279134 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0040405 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Therapeutic procedure Breast cancer recurrent | Second Cancer | Contralateral breast cancer | Exception Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
current treatment for bc recurrence or second malignancy (including contralateral bc) with the exception of non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix;
boolean
C0087111 (UMLS CUI [1,1])
C0278493 (UMLS CUI [1,2])
C0751623 (UMLS CUI [2])
C1096616 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0851140 (UMLS CUI [5,3])
Heart Disease | Congestive heart failure | Acute Coronary Syndrome | Coronary revascularisation | Dysfunction Heart Valve Symptomatic | Cardiomyopathy | Congenital Heart Defects
Item
history of cardiac disease (chf, acute coronary syndrome, coronary revascularization procedure, symptomatic valvular dysfunction, cardiomyopathy or congenital heart defect) before diagnosis and treatment for bc;
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0948089 (UMLS CUI [3])
C0877341 (UMLS CUI [4])
C3887504 (UMLS CUI [5,1])
C0018826 (UMLS CUI [5,2])
C0231220 (UMLS CUI [5,3])
C0878544 (UMLS CUI [6])
C0018798 (UMLS CUI [7])
Mental handicap Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance
Item
mental disability or psychological condition potentially hampering compliance with the study protocol;
boolean
C1306341 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Comprehension Dutch Language Insufficient
Item
insufficient understanding of the dutch language.
boolean
C0233733 (UMLS CUI [1,1])
C0376241 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
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