ID

38215

Beschreibung

Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02470819

Link

https://clinicaltrials.gov/show/NCT02470819

Stichworte

Versionen (1)
  1. 28.09.19 28.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. September 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02470819

Englisch

Eligibility Breast Cancer NCT02470819

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
life expectancy of >3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
diagnosis of metastatic breast cancer with measurable disease
Beschreibung

Secondary malignant neoplasm of female breast | Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2]
C1513041
age greater than or equal to 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
able to undergo two biopsies to obtain tissue with first biopsy required and second biopsy optional
Beschreibung

Biopsy Quantity | Obtain Tissue specimen | Biopsy first Required | Biopsy second Optional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1301820
UMLS CUI [2,2]
C1292533
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0205435
UMLS CUI [3,3]
C1514873
UMLS CUI [4,1]
C0005558
UMLS CUI [4,2]
C0205436
UMLS CUI [4,3]
C1518600
have failed or unable to tolerate previous treatment regimen
Beschreibung

Prior Therapy failed | Prior Therapy Receive Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1299582
adequate organ and bone marrow function as defined by anc ≥ 1.5 x 109/l; hgb 9 g/dl; platelets greater than 100 x 109/l; creatinine ≤ 1.5 mg/dl; bilirubin ≤ 2.5 x uln; ast and alt ≤ 2.5 x uln (or ≤ 5 x uln if due to underlying liver metastases); inr ≤
Beschreibung

Organ function | Bone Marrow function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Etiology Secondary malignant neoplasm of liver | INR

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0201976
UMLS CUI [7]
C1278039
UMLS CUI [8]
C0201899
UMLS CUI [9]
C0201836
UMLS CUI [10,1]
C0015127
UMLS CUI [10,2]
C0494165
UMLS CUI [11]
C0525032
1.5 x uln (except in the case of anticoagulation therapy)
Beschreibung

Exception Anticoagulation Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0003281
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic lesions that are not accessible to biopsy
Beschreibung

Metastatic Lesion Inappropriate Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513183
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0005558
symptomatic cns metastasis
Beschreibung

CNS metastases Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
previous history of another malignancy within 5 years of study entry
Beschreibung

Cancer Other

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
uncontrolled concurrent illness
Beschreibung

Comorbidity Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
known hiv, hbb, and/or hcv infection
Beschreibung

HIV Infection | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
pregnant or breast feeding or childbearing potential and not using adequate birth control
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
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Ähnliche Modelle

Eligibility Breast Cancer NCT02470819

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Life Expectancy
Item
life expectancy of >3 months
boolean
C0023671 (UMLS CUI [1])
Secondary malignant neoplasm of female breast | Measurable Disease
Item
diagnosis of metastatic breast cancer with measurable disease
boolean
C0346993 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Age
Item
age greater than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Biopsy Quantity | Obtain Tissue specimen | Biopsy first Required | Biopsy second Optional
Item
able to undergo two biopsies to obtain tissue with first biopsy required and second biopsy optional
boolean
C0005558 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301820 (UMLS CUI [2,1])
C1292533 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C0205435 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C0005558 (UMLS CUI [4,1])
C0205436 (UMLS CUI [4,2])
C1518600 (UMLS CUI [4,3])
Prior Therapy failed | Prior Therapy Receive Unable
Item
have failed or unable to tolerate previous treatment regimen
boolean
C1514463 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Organ function | Bone Marrow function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Etiology Secondary malignant neoplasm of liver | INR
Item
adequate organ and bone marrow function as defined by anc ≥ 1.5 x 109/l; hgb 9 g/dl; platelets greater than 100 x 109/l; creatinine ≤ 1.5 mg/dl; bilirubin ≤ 2.5 x uln; ast and alt ≤ 2.5 x uln (or ≤ 5 x uln if due to underlying liver metastases); inr ≤
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0948762 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0015127 (UMLS CUI [10,1])
C0494165 (UMLS CUI [10,2])
C0525032 (UMLS CUI [11])
Exception Anticoagulation Therapy
Item
1.5 x uln (except in the case of anticoagulation therapy)
boolean
C1705847 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Metastatic Lesion Inappropriate Biopsy
Item
metastatic lesions that are not accessible to biopsy
boolean
C1513183 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
CNS metastases Symptomatic
Item
symptomatic cns metastasis
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Cancer Other
Item
previous history of another malignancy within 5 years of study entry
boolean
C1707251 (UMLS CUI [1])
Comorbidity Uncontrolled
Item
uncontrolled concurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
HIV Infection | Hepatitis B | Hepatitis C
Item
known hiv, hbb, and/or hcv infection
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
pregnant or breast feeding or childbearing potential and not using adequate birth control
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
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