ID

24154

Beschrijving

Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00577122

Link

https://clinicaltrials.gov/show/NCT00577122

Trefwoorden

  1. 26-07-17 26-07-17 -
Geüploaded op

26 juli 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Estrogen Receptor-negative Breast Cancer NCT00577122

Eligibility Estrogen Receptor-negative Breast Cancer NCT00577122

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease
Beschrijving

Breast adenocarcinoma | Measurable Disease Recurrent Local | Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C2945760
UMLS CUI [2,3]
C0205276
UMLS CUI [3]
C0027627
primary tumor must be er negative and pr negative
Beschrijving

Primary tumor Estrogen receptor negative Progesterone receptor negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0279756
UMLS CUI [1,3]
C0279766
patients must be post-menopausal
Beschrijving

Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
patients may have had up to 3 prior chemotherapy regimens for recurrent/metastatic disease
Beschrijving

Chemotherapy Regimen Quantity Recurrent disease | Chemotherapy Regimen Quantity Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
adequate organ function as evidenced by laboratory studies outlined in section 3.6 of the protocol
Beschrijving

Organ function Laboratory studies

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0681827
patients with treated, asymptomatic brain metastases are eligible provided chronic steroid therapy is not required
Beschrijving

Metastatic malignant neoplasm to brain Asymptomatic Treated | STEROID TREATMENT CHRONIC Requirement Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231221
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C0749016
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have extensive pleural effusion or ascites
Beschrijving

Pleural effusion Extensive | Ascites

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0205231
UMLS CUI [2]
C0003962
patients must not have history of dvt or pulmonary embolism w/in past 12 mo
Beschrijving

Deep Vein Thrombosis | Pulmonary Embolism

Datatype

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
patients must not have had chemotherapy or hormonal therapy within 2 weeks of study entry
Beschrijving

Chemotherapy | Hormone Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
patients must not have had radiation therapy within 1 week of study entry.
Beschrijving

Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C1522449

Similar models

Eligibility Estrogen Receptor-negative Breast Cancer NCT00577122

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma | Measurable Disease Recurrent Local | Neoplasm Metastasis
Item
histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease
boolean
C0858252 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3])
Primary tumor Estrogen receptor negative Progesterone receptor negative
Item
primary tumor must be er negative and pr negative
boolean
C0677930 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0279766 (UMLS CUI [1,3])
Postmenopausal state
Item
patients must be post-menopausal
boolean
C0232970 (UMLS CUI [1])
Chemotherapy Regimen Quantity Recurrent disease | Chemotherapy Regimen Quantity Neoplasm Metastasis
Item
patients may have had up to 3 prior chemotherapy regimens for recurrent/metastatic disease
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Organ function Laboratory studies
Item
adequate organ function as evidenced by laboratory studies outlined in section 3.6 of the protocol
boolean
C0678852 (UMLS CUI [1,1])
C0681827 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Asymptomatic Treated | STEROID TREATMENT CHRONIC Requirement Absent
Item
patients with treated, asymptomatic brain metastases are eligible provided chronic steroid therapy is not required
boolean
C0220650 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C0749016 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pleural effusion Extensive | Ascites
Item
patients must not have extensive pleural effusion or ascites
boolean
C0032227 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
Deep Vein Thrombosis | Pulmonary Embolism
Item
patients must not have history of dvt or pulmonary embolism w/in past 12 mo
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
Chemotherapy | Hormone Therapy
Item
patients must not have had chemotherapy or hormonal therapy within 2 weeks of study entry
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Therapeutic radiology procedure
Item
patients must not have had radiation therapy within 1 week of study entry.
boolean
C1522449 (UMLS CUI [1])

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