ID

26092

Beschrijving

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

Trefwoorden

Versies (1)
  1. 09-10-17 09-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 oktober 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT00639366

Engels

Eligibility Breast Cancer NCT00639366

1 Formulieren  
Criteria
Beschrijving

Criteria

histologically proven breast carcinoma
Beschrijving

Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
metastatic or locally advanced disease
Beschrijving

Neoplasm Metastasis | Advanced disease Locally

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0679246
UMLS CUI [2,2]
C1517927
must demonstrate her2 3+ positivity on ihc or 2+ over-expression and fish test demonstrating c-erb2 gene amplification
Beschrijving

HER2/Neu Positive Immunohistochemistry | erbB-2 Receptor Protein Overexpression | HER2 gene amplification FISH

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348909
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C1514559
UMLS CUI [3,1]
C1512127
UMLS CUI [3,2]
C0162789
no known or suspected brain metastases or cns disease, as defined by the presence of any of the following key symptoms:
Beschrijving

Metastatic malignant neoplasm to brain Absent | Metastatic malignant neoplasm to brain Suspected Absent | CNS disorder Absent | Symptoms Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0007682
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C1542147
headache
Beschrijving

Headache

Datatype

boolean

Alias
UMLS CUI [1]
C0018681
nausea and/or vomiting
Beschrijving

Nausea | Vomiting

Datatype

boolean

Alias
UMLS CUI [1]
C0027497
UMLS CUI [2]
C0042963
clinical signs of raised intracranial pressure
Beschrijving

Sign or Symptom Raised intracranial pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0437215
seizures
Beschrijving

Seizures

Datatype

boolean

Alias
UMLS CUI [1]
C0036572
focal symptoms
Beschrijving

Symptoms Focal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205234
cognitive dysfunction
Beschrijving

Impaired cognition

Datatype

boolean

Alias
UMLS CUI [1]
C0338656
affective disorder
Beschrijving

Mood Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0525045
hormone receptor status not specified
Beschrijving

Hormone Receptor Status Unspecified

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
postmenopausal status not specified
Beschrijving

Postmenopausal state Unspecified

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0205370
ecog performance status 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
patients must a-priori be suitable for trastuzumab (herceptin®) +/- chemotherapy in terms of bone marrow, hepatic, and renal function
Beschrijving

Patients Appropriate Chemotherapy | Trastuzumab | Herceptin | Bone Marrow function | Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0392920
UMLS CUI [2]
C0728747
UMLS CUI [3]
C0338204
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C0031843
UMLS CUI [5]
C0232741
UMLS CUI [6]
C0232804
no prior history of cerebrovascular disease or neurological disorder including seizures
Beschrijving

Cerebrovascular Disorders Absent | Nervous system disorder Absent | Seizures Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007820
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0036572
UMLS CUI [3,2]
C0332197
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
no prior cranial radiotherapy
Beschrijving

Absence Therapeutic radiology procedure cranial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0037303
no prior neurosurgery
Beschrijving

Neurosurgical Procedures Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0524850
UMLS CUI [1,2]
C0332197
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00639366

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
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])
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])
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])
Headache
Item
headache
boolean
C0018681 (UMLS CUI [1])
Nausea | Vomiting
Item
nausea and/or vomiting
boolean
C0027497 (UMLS CUI [1])
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])
Seizures
Item
seizures
boolean
C0036572 (UMLS CUI [1])
Symptoms Focal
Item
focal symptoms
boolean
C1457887 (UMLS CUI [1,1])
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])
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])
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])
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])
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])
Neurosurgical Procedures Absent
Item
no prior neurosurgery
boolean
C0524850 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial