ID

37779

Beschrijving

Study of Tamoxifen Dose Escalation in Breast Cancer Patients With CYP2D6 Polymorphisms; ODM derived from: https://clinicaltrials.gov/show/NCT01075802

Link

https://clinicaltrials.gov/show/NCT01075802

Trefwoorden

  1. 24-08-19 24-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 augustus 2019

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.

Itemgroep Commentaren voor :

Item Commentaren voor :

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

Eligibility Breast Cancer NCT01075802

Eligibility Breast Cancer NCT01075802

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
ecog performance status ≤ 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy ≥ 6 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
histologically or cytologically confirmed early, locally advanced or metastatic breast cancer
Beschrijving

Early-Stage Breast Carcinoma | Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1]
C2986665
UMLS CUI [2]
C3495949
UMLS CUI [3]
C0346993
oestrogen receptor positive
Beschrijving

Estrogen receptor positive

Datatype

boolean

Alias
UMLS CUI [1]
C0279754
about to start tamoxifen treatment or already on tamoxifen 20mg daily
Beschrijving

Tamoxifen Medication started | Tamoxifen U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039286
UMLS CUI [1,2]
C0451613
UMLS CUI [2,1]
C0039286
UMLS CUI [2,2]
C0456683
adequate hepatic and renal function
Beschrijving

Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent chemotherapy or radiotherapy
Beschrijving

Chemotherapy | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
treatment with medications that may alter cytochrome p450 (cyp450)3a4/5 and cyp2d6 activities
Beschrijving

Pharmaceutical Preparations Changing CYP3A4 Activity | Pharmaceutical Preparations Changing CYP3A5 Activity | Pharmaceutical Preparations Changing CYP2D6 Activity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C3714798
UMLS CUI [1,4]
C0205177
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C3714750
UMLS CUI [2,4]
C0205177
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0057223
UMLS CUI [3,4]
C0205177
history of thrombosis
Beschrijving

Thrombosis

Datatype

boolean

Alias
UMLS CUI [1]
C0040053
history of non-compliance with previous or current treatment;
Beschrijving

Treatment Compliance Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C0332197
medical or psychiatric conditions that compromise the patient's ability to give informed consent
Beschrijving

Medical condition compromises Informed Consent | Mental condition compromises Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0021430

Similar models

Eligibility Breast Cancer NCT01075802

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥ 6 months
boolean
C0023671 (UMLS CUI [1])
Early-Stage Breast Carcinoma | Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
histologically or cytologically confirmed early, locally advanced or metastatic breast cancer
boolean
C2986665 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C0346993 (UMLS CUI [3])
Estrogen receptor positive
Item
oestrogen receptor positive
boolean
C0279754 (UMLS CUI [1])
Tamoxifen Medication started | Tamoxifen U/day
Item
about to start tamoxifen treatment or already on tamoxifen 20mg daily
boolean
C0039286 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
C0039286 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Liver function | Renal function
Item
adequate hepatic and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure
Item
concurrent chemotherapy or radiotherapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Pharmaceutical Preparations Changing CYP3A4 Activity | Pharmaceutical Preparations Changing CYP3A5 Activity | Pharmaceutical Preparations Changing CYP2D6 Activity
Item
treatment with medications that may alter cytochrome p450 (cyp450)3a4/5 and cyp2d6 activities
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C3714798 (UMLS CUI [1,3])
C0205177 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C3714750 (UMLS CUI [2,3])
C0205177 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0057223 (UMLS CUI [3,3])
C0205177 (UMLS CUI [3,4])
Thrombosis
Item
history of thrombosis
boolean
C0040053 (UMLS CUI [1])
Treatment Compliance Absent
Item
history of non-compliance with previous or current treatment;
boolean
C4319828 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Medical condition compromises Informed Consent | Mental condition compromises Informed Consent
Item
medical or psychiatric conditions that compromise the patient's ability to give informed consent
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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