ID

37285

Beschrijving

REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity); ODM derived from: https://clinicaltrials.gov/show/NCT02079272

Link

https://clinicaltrials.gov/show/NCT02079272

Trefwoorden

Versies (1)
  1. 13-07-19 13-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 juli 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Toxicity Due to Radiotherapy NCT02079272

Engels

Eligibility Toxicity Due to Radiotherapy NCT02079272

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
women treated surgically for left or right breast cancer and for who adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly lymph node chains,
Beschrijving

Gender | Operative Surgical Procedures Left-Sided Breast Neoplasm | Operative Surgical Procedures Right-Sided Breast Neoplasm | Radiotherapy to breast Adjuvant | Radiotherapy to chest wall Adjuvant | Radiotherapy to lymph nodes Adjuvant

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C4042788
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C4042789
UMLS CUI [4,1]
C0948310
UMLS CUI [4,2]
C1522673
UMLS CUI [5,1]
C1998066
UMLS CUI [5,2]
C1522673
UMLS CUI [6,1]
C1504399
UMLS CUI [6,2]
C1522673
age between 40 and 70 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
adjuvant radiotherapy is helical tomotherapy performed at institut claudius regaud(toulouse, france)
Beschrijving

Adjuvant Radiotherapy | Helical Tomotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0242939
UMLS CUI [2]
C1831735
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
indication of adjuvant chemotherapy
Beschrijving

Indication Adjuvant Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0085533
clinically or radiologically detectable metastasis
Beschrijving

Neoplasm Metastasis Clinical Detectable | Neoplasm Metastasis Detectable Radiology

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C3830527
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C3830527
UMLS CUI [2,3]
C0043299
personal history of coronary artery or myocardial disease
Beschrijving

Coronary Artery Disease | Cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0878544
personal history of breast cancer or other cancer requiring radiotherapy to the chest
Beschrijving

Breast Carcinoma Requirement Radiotherapy to thorax | Cancer Other Requirement Radiotherapy to thorax

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C4038705
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C4038705
contraindications to injection of iodinated contrast ( for ct ) : pregnancy , renal failure, allergy.
Beschrijving

Medical contraindication Iodinated contrast agent Injection | Pregnancy | Kidney Failure | Hypersensitivity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0879373
UMLS CUI [1,3]
C1828121
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0035078
UMLS CUI [4]
C0020517
pregnancy, lactation
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
before radiotherapy, lvef <50%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
before radiotherapy, longitudinal strain > - 16 %
Beschrijving

Longitudinal strain rate.diastole | Longitudinal strain rate.systole

Datatype

boolean

Alias
UMLS CUI [1]
C4265366
UMLS CUI [2]
C4265374
before radiotherapy,longitudinal strain rate <1% / s
Beschrijving

Longitudinal strain rate.diastole | Longitudinal strain rate.systole

Datatype

boolean

Alias
UMLS CUI [1]
C4265366
UMLS CUI [2]
C4265374
before radiotherapy, segmental wall motion abnormality
Beschrijving

Segmental wall motion Abnormality

Datatype

boolean

Alias
UMLS CUI [1,1]
C0807885
UMLS CUI [1,2]
C1704258
coronary ct before radiotherapy showing that a therapeutic treatment is required
Beschrijving

CT Coronary | Therapeutic procedure Required

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C1522318
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1514873
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Similar models

Eligibility Toxicity Due to Radiotherapy NCT02079272

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Operative Surgical Procedures Left-Sided Breast Neoplasm | Operative Surgical Procedures Right-Sided Breast Neoplasm | Radiotherapy to breast Adjuvant | Radiotherapy to chest wall Adjuvant | Radiotherapy to lymph nodes Adjuvant
Item
women treated surgically for left or right breast cancer and for who adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly lymph node chains,
boolean
C0079399 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C4042788 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C4042789 (UMLS CUI [3,2])
C0948310 (UMLS CUI [4,1])
C1522673 (UMLS CUI [4,2])
C1998066 (UMLS CUI [5,1])
C1522673 (UMLS CUI [5,2])
C1504399 (UMLS CUI [6,1])
C1522673 (UMLS CUI [6,2])
Age
Item
age between 40 and 70 years
boolean
C0001779 (UMLS CUI [1])
Adjuvant Radiotherapy | Helical Tomotherapy
Item
adjuvant radiotherapy is helical tomotherapy performed at institut claudius regaud(toulouse, france)
boolean
C0242939 (UMLS CUI [1])
C1831735 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Indication Adjuvant Chemotherapy
Item
indication of adjuvant chemotherapy
boolean
C3146298 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
Neoplasm Metastasis Clinical Detectable | Neoplasm Metastasis Detectable Radiology
Item
clinically or radiologically detectable metastasis
boolean
C0027627 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C3830527 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C0043299 (UMLS CUI [2,3])
Coronary Artery Disease | Cardiomyopathy
Item
personal history of coronary artery or myocardial disease
boolean
C1956346 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
Breast Carcinoma Requirement Radiotherapy to thorax | Cancer Other Requirement Radiotherapy to thorax
Item
personal history of breast cancer or other cancer requiring radiotherapy to the chest
boolean
C0678222 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C4038705 (UMLS CUI [1,3])
C1707251 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C4038705 (UMLS CUI [2,3])
Medical contraindication Iodinated contrast agent Injection | Pregnancy | Kidney Failure | Hypersensitivity
Item
contraindications to injection of iodinated contrast ( for ct ) : pregnancy , renal failure, allergy.
boolean
C1301624 (UMLS CUI [1,1])
C0879373 (UMLS CUI [1,2])
C1828121 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
C0020517 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnancy, lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Left ventricular ejection fraction
Item
before radiotherapy, lvef <50%
boolean
C0428772 (UMLS CUI [1])
Longitudinal strain rate.diastole | Longitudinal strain rate.systole
Item
before radiotherapy, longitudinal strain > - 16 %
boolean
C4265366 (UMLS CUI [1])
C4265374 (UMLS CUI [2])
Longitudinal strain rate.diastole | Longitudinal strain rate.systole
Item
before radiotherapy,longitudinal strain rate <1% / s
boolean
C4265366 (UMLS CUI [1])
C4265374 (UMLS CUI [2])
Segmental wall motion Abnormality
Item
before radiotherapy, segmental wall motion abnormality
boolean
C0807885 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
CT Coronary | Therapeutic procedure Required
Item
coronary ct before radiotherapy showing that a therapeutic treatment is required
boolean
C0040405 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
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