Informações:
Falhas:
ID
26092
Descrição
Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00639366
Link
https://clinicaltrials.gov/show/NCT00639366
Palavras-chave
Versões (1)
- 09/10/2017 09/10/2017 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
9 de outubro de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00639366
Eligibility Breast Cancer NCT00639366
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00639366
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Breast Carcinoma
Item
histologically proven breast carcinoma
boolean
C0678222 (UMLS CUI [1])
Neoplasm Metastasis | Advanced disease Locally
Item
metastatic or locally advanced disease
boolean
C0027627 (UMLS CUI [1])
C0679246 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
HER2/Neu Positive Immunohistochemistry | erbB-2 Receptor Protein Overexpression | HER2 gene amplification FISH
Item
must demonstrate her2 3+ positivity on ihc or 2+ over-expression and fish test demonstrating c-erb2 gene amplification
boolean
C2348909 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0069515 (UMLS CUI [2,1])
C1514559 (UMLS CUI [2,2])
C1512127 (UMLS CUI [3,1])
C0162789 (UMLS CUI [3,2])
C0021044 (UMLS CUI [1,2])
C0069515 (UMLS CUI [2,1])
C1514559 (UMLS CUI [2,2])
C1512127 (UMLS CUI [3,1])
C0162789 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain Absent | Metastatic malignant neoplasm to brain Suspected Absent | CNS disorder Absent | Symptoms Main
Item
no known or suspected brain metastases or cns disease, as defined by the presence of any of the following key symptoms:
boolean
C0220650 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0007682 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1457887 (UMLS CUI [4,1])
C1542147 (UMLS CUI [4,2])
C0332197 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0007682 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1457887 (UMLS CUI [4,1])
C1542147 (UMLS CUI [4,2])
Headache
Item
headache
boolean
C0018681 (UMLS CUI [1])
Nausea | Vomiting
Item
nausea and/or vomiting
boolean
C0027497 (UMLS CUI [1])
C0042963 (UMLS CUI [2])
C0042963 (UMLS CUI [2])
Sign or Symptom Raised intracranial pressure
Item
clinical signs of raised intracranial pressure
boolean
C3540840 (UMLS CUI [1,1])
C0437215 (UMLS CUI [1,2])
C0437215 (UMLS CUI [1,2])
Seizures
Item
seizures
boolean
C0036572 (UMLS CUI [1])
Symptoms Focal
Item
focal symptoms
boolean
C1457887 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,2])
Impaired cognition
Item
cognitive dysfunction
boolean
C0338656 (UMLS CUI [1])
Mood Disorders
Item
affective disorder
boolean
C0525045 (UMLS CUI [1])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Postmenopausal state Unspecified
Item
postmenopausal status not specified
boolean
C0232970 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Patients Appropriate Chemotherapy | Trastuzumab | Herceptin | Bone Marrow function | Liver function | Renal function
Item
patients must a-priori be suitable for trastuzumab (herceptin®) +/- chemotherapy in terms of bone marrow, hepatic, and renal function
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2])
C0338204 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0031843 (UMLS CUI [4,2])
C0232741 (UMLS CUI [5])
C0232804 (UMLS CUI [6])
C1548787 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2])
C0338204 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0031843 (UMLS CUI [4,2])
C0232741 (UMLS CUI [5])
C0232804 (UMLS CUI [6])
Cerebrovascular Disorders Absent | Nervous system disorder Absent | Seizures Absent
Item
no prior history of cerebrovascular disease or neurological disorder including seizures
boolean
C0007820 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0036572 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0332197 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0036572 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Absence Therapeutic radiology procedure cranial
Item
no prior cranial radiotherapy
boolean
C0332197 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0037303 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,2])
C0037303 (UMLS CUI [1,3])
Neurosurgical Procedures Absent
Item
no prior neurosurgery
boolean
C0524850 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])