ID

16365

Beschrijving

ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00331097

Link

https://clinicaltrials.gov/show/NCT00331097

Trefwoorden

Versies (1)
  1. 12-07-16 12-07-16 -
Geüploaded op

12 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 NCT00331097

Engels

Eligibility Breast Cancer NCT00331097

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed invasive unilateral breast cancer
Beschrijving

Invasive carcinoma of breast Unilateral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205092
age > 65 and < 80 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
intermediate-high risk of recurrence according to st. gallen criteria: er negative and pgr negative, or axillary lymph node metastasis, or tumor size > 2 cm, or tumor grade 2 or 3 (intermediate or high)
Beschrijving

Recurrence High risk Intermediate | Estrogen receptor negative | progesterone receptor negative | AXILLARY LYMPH NODE METASTASIS | Tumor size | TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C2825055
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C3640764
UMLS CUI [2]
C0279756
UMLS CUI [3]
C0279766
UMLS CUI [4]
C0741344
UMLS CUI [5]
C0475440
UMLS CUI [6]
C3258246
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
performance status >1
Beschrijving

performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
distant metastasis
Beschrijving

Distant metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C1275402
concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
Beschrijving

Malignant Neoplasms | Basal cell carcinoma Treated Adequate | Spinocellular carcinoma Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205411
UMLS CUI [3,1]
C1168311
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205411
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
UMLS CUI [4,3]
C0205411
previous breast cancer treatment
Beschrijving

Breast Cancer Therapeutic Procedure

Datatype

boolean

Alias
UMLS CUI [1]
C1511300
neutrophils < 2000/mm3 or platelets < 100000/mm3 or haemoglobin < 10 g/dl
Beschrijving

Absolute neutrophil count | Blood Platelets | Hemoglobin

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0019046
creatinine > 1.25 the upper normal limit
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
got and-or gpt and/or bilirubin > 1.25 the upper normal limit
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
concomitant conditions that contraindicate the use of the drugs in the protocol
Beschrijving

Medical contraindication Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
incapacity or refusal to provide informed consent
Beschrijving

Informed Consent Unable | Informed Consent Refused

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1705116
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00331097

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Unilateral
Item
histologically confirmed invasive unilateral breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
Age
Item
age > 65 and < 80 years
boolean
C0001779 (UMLS CUI [1])
Recurrence High risk Intermediate | Estrogen receptor negative | progesterone receptor negative | AXILLARY LYMPH NODE METASTASIS | Tumor size | TNM clinical staging
Item
intermediate-high risk of recurrence according to st. gallen criteria: er negative and pgr negative, or axillary lymph node metastasis, or tumor size > 2 cm, or tumor grade 2 or 3 (intermediate or high)
boolean
C2825055 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C3640764 (UMLS CUI [1,3])
C0279756 (UMLS CUI [2])
C0279766 (UMLS CUI [3])
C0741344 (UMLS CUI [4])
C0475440 (UMLS CUI [5])
C3258246 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
performance status
Item
performance status >1
boolean
C1518965 (UMLS CUI [1])
Distant metastasis
Item
distant metastasis
boolean
C1275402 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma Treated Adequate | Spinocellular carcinoma Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate
Item
concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C1168311 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0205411 (UMLS CUI [4,3])
Breast Cancer Therapeutic Procedure
Item
previous breast cancer treatment
boolean
C1511300 (UMLS CUI [1])
Absolute neutrophil count | Blood Platelets | Hemoglobin
Item
neutrophils < 2000/mm3 or platelets < 100000/mm3 or haemoglobin < 10 g/dl
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
Creatinine measurement, serum
Item
creatinine > 1.25 the upper normal limit
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
got and-or gpt and/or bilirubin > 1.25 the upper normal limit
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Medical contraindication Investigational New Drugs
Item
concomitant conditions that contraindicate the use of the drugs in the protocol
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Informed Consent Unable | Informed Consent Refused
Item
incapacity or refusal to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
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