ID

13646

Description

A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01423890

Lien

https://clinicaltrials.gov/show/NCT01423890

Mots-clés

  1. 22/02/2016 22/02/2016 -
Téléchargé le

22 février 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01423890

Eligibility Breast Cancer NCT01423890

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women or men with histologic evidence of invasive breast cancer (ductal, lobular or mixed disease).
Description

invasive breast cancer

Type de données

boolean

Alias
UMLS CUI [1]
C0853879
surgical resection including breast conserving surgery or modified radical mastectomy or simple mastectomy, within the last four months.
Description

mastectomy

Type de données

boolean

Alias
UMLS CUI [1]
C0024881
axillary lymph nodes assessed for tumor by:
Description

axillary lymph nodes

Type de données

boolean

Alias
UMLS CUI [1]
C0729594
(i) sentinel node biopsy, or (ii) axillary node dissection, or (iii) both
Description

sentinel node biopsy; axillary node dissection

Type de données

boolean

Alias
UMLS CUI [1]
C0796693
UMLS CUI [2]
C0193867
axillary lymph node assessment negative for cancer, or positive only for micrometastases (i.e., cancer <2mm by h&e stain).
Description

axillary lymph node; micrometastases

Type de données

boolean

Alias
UMLS CUI [1]
C0729594
UMLS CUI [2]
C1513276
tumor is estrogen receptor (er) positive.
Description

estrogen receptor positive

Type de données

boolean

Alias
UMLS CUI [1]
C0034804
receiving or to receive adjuvant endocrine therapy (i.e., tamoxifen or aromatase inhibitor).
Description

endocrine therapy; tamoxifen

Type de données

boolean

Alias
UMLS CUI [1,1]
C1880501
UMLS CUI [1,2]
C0677850
UMLS CUI [2]
C0039286
being considered for adjuvant chemotherapy.
Description

adjuvant chemotherapy

Type de données

boolean

Alias
UMLS CUI [1]
C0085533
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
axillary lymph node positive for cancer.
Description

axillary lymph node positive

Type de données

boolean

Alias
UMLS CUI [1]
C0677929
patients with inoperable locally advanced breast cancer.
Description

advanced breast cancer inoperable

Type de données

boolean

Alias
UMLS CUI [1,1]
C3495917
UMLS CUI [1,2]
C0205187
metastatic breast cancer, including local ipsilateral recurrence.
Description

metastatic breast cancer

Type de données

boolean

Alias
UMLS CUI [1,1]
C0036525
UMLS CUI [1,2]
C0678222
her2 neu positive.
Description

her2 positive

Type de données

boolean

Alias
UMLS CUI [1]
C1960398
physician/patient unwilling to comply with study protocol.
Description

compliance

Type de données

boolean

Alias
UMLS CUI [1]
C1321605
inability to provide informed consent (e.g. dementia or severe cognitive impairment).
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Breast Cancer NCT01423890

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
invasive breast cancer
Item
women or men with histologic evidence of invasive breast cancer (ductal, lobular or mixed disease).
boolean
C0853879 (UMLS CUI [1])
mastectomy
Item
surgical resection including breast conserving surgery or modified radical mastectomy or simple mastectomy, within the last four months.
boolean
C0024881 (UMLS CUI [1])
axillary lymph nodes
Item
axillary lymph nodes assessed for tumor by:
boolean
C0729594 (UMLS CUI [1])
sentinel node biopsy; axillary node dissection
Item
(i) sentinel node biopsy, or (ii) axillary node dissection, or (iii) both
boolean
C0796693 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
axillary lymph node; micrometastases
Item
axillary lymph node assessment negative for cancer, or positive only for micrometastases (i.e., cancer <2mm by h&e stain).
boolean
C0729594 (UMLS CUI [1])
C1513276 (UMLS CUI [2])
estrogen receptor positive
Item
tumor is estrogen receptor (er) positive.
boolean
C0034804 (UMLS CUI [1])
endocrine therapy; tamoxifen
Item
receiving or to receive adjuvant endocrine therapy (i.e., tamoxifen or aromatase inhibitor).
boolean
C1880501 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0039286 (UMLS CUI [2])
adjuvant chemotherapy
Item
being considered for adjuvant chemotherapy.
boolean
C0085533 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
axillary lymph node positive
Item
axillary lymph node positive for cancer.
boolean
C0677929 (UMLS CUI [1])
advanced breast cancer inoperable
Item
patients with inoperable locally advanced breast cancer.
boolean
C3495917 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
metastatic breast cancer
Item
metastatic breast cancer, including local ipsilateral recurrence.
boolean
C0036525 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
her2 positive
Item
her2 neu positive.
boolean
C1960398 (UMLS CUI [1])
compliance
Item
physician/patient unwilling to comply with study protocol.
boolean
C1321605 (UMLS CUI [1])
informed consent
Item
inability to provide informed consent (e.g. dementia or severe cognitive impairment).
boolean
C0021430 (UMLS CUI [1])

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