ID

16385

Beschrijving

Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00431080

Link

https://clinicaltrials.gov/show/NCT00431080

Trefwoorden

Versies (1)
  1. 14-07-16 14-07-16 -
Geüploaded op

14 juli 2016

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 NCT00431080

Engels

Eligibility Breast Cancer NCT00431080

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
Beschrijving

Gender | Breast adenocarcinoma Ductal Invasive Unilateral | Breast adenocarcinoma Lobular

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0858252
UMLS CUI [2,2]
C1512083
UMLS CUI [2,3]
C0205281
UMLS CUI [2,4]
C0205092
UMLS CUI [3,1]
C0858252
UMLS CUI [3,2]
C0205417
within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
Beschrijving

Excision primary tumor | Surgical margin uninvolved by tumor | Excision of axillary lymph nodes Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0332648
UMLS CUI [3,1]
C0193867
UMLS CUI [3,2]
C1265611
tumor involvement of at least one axillary lymph node
Beschrijving

Axillary lymph nodes Involvement with Neoplasm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0027651
absence of any clinical or radiological evidence of local or metastatic disease
Beschrijving

Local disease Evidence Absent | Metastatic Neoplasm Evidence Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277565
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C2939420
UMLS CUI [2,2]
C0332120
UMLS CUI [2,3]
C0332197
premenopausal or postmenopausal women aged 18-75 years old
Beschrijving

Premenopausal | Postmenopausal state | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0279752
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0001779
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
Beschrijving

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0019046
adequate liver (bilirubin <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
Beschrijving

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
adequate cardiac function (lvef>50%)
Beschrijving

Cardiac function | Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
written informed consent
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive pregnancy test.
Beschrijving

Pregnancy test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0240802
psychiatric illness or social situation that would preclude study compliance.
Beschrijving

Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
other concurrent uncontrolled illness.
Beschrijving

Illness Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
Beschrijving

Antineoplastic Therapy | Hormone Therapy | Therapeutic radiology procedure | Chemotherapy | Biological Factors

Datatype

boolean

Alias
UMLS CUI [1]
C2346834
UMLS CUI [2]
C0279025
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0392920
UMLS CUI [5]
C0005515
previous history of other invasive malignancy other than non-melanomatous skin cancer.
Beschrijving

Malignant Neoplasms Invasive | Skin carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205281
UMLS CUI [2]
C0699893
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00431080

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast adenocarcinoma Ductal Invasive Unilateral | Breast adenocarcinoma Lobular
Item
women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
boolean
C0079399 (UMLS CUI [1])
C0858252 (UMLS CUI [2,1])
C1512083 (UMLS CUI [2,2])
C0205281 (UMLS CUI [2,3])
C0205092 (UMLS CUI [2,4])
C0858252 (UMLS CUI [3,1])
C0205417 (UMLS CUI [3,2])
Excision primary tumor | Surgical margin uninvolved by tumor | Excision of axillary lymph nodes Quantity
Item
within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
boolean
C0728940 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0332648 (UMLS CUI [2])
C0193867 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Axillary lymph nodes Involvement with Neoplasm
Item
tumor involvement of at least one axillary lymph node
boolean
C0729594 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
Local disease Evidence Absent | Metastatic Neoplasm Evidence Absent
Item
absence of any clinical or radiological evidence of local or metastatic disease
boolean
C0277565 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C2939420 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Premenopausal | Postmenopausal state | Age
Item
premenopausal or postmenopausal women aged 18-75 years old
boolean
C0279752 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate liver (bilirubin <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Cardiac function | Left ventricular ejection fraction
Item
adequate cardiac function (lvef>50%)
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy test positive
Item
positive pregnancy test.
boolean
C0240802 (UMLS CUI [1])
Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited
Item
psychiatric illness or social situation that would preclude study compliance.
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Illness Uncontrolled
Item
other concurrent uncontrolled illness.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Antineoplastic Therapy | Hormone Therapy | Therapeutic radiology procedure | Chemotherapy | Biological Factors
Item
prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
boolean
C2346834 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0005515 (UMLS CUI [5])
Malignant Neoplasms Invasive | Skin carcinoma
Item
previous history of other invasive malignancy other than non-melanomatous skin cancer.
boolean
C0006826 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0699893 (UMLS CUI [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