ID

43578

Beschreibung

A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00338286

Link

https://clinicaltrials.gov/show/NCT00338286

Stichworte

Versionen (2)
  1. 12.01.17 12.01.17 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00338286

Englisch

Eligibility Breast Cancer NCT00338286

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed (e.g., slide of tissue) breast cancer
Beschreibung

Breast Carcinoma Slide Breast tissue sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1705201
UMLS CUI [1,3]
C0444070
her2/neu positive or negative
Beschreibung

HER2/Neu Positive | HER2/Neu Negative

Datentyp

boolean

Alias
UMLS CUI [1]
C2348909
UMLS CUI [2]
C2348908
clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (m1) lesion prior to starting the current chemotherapy
Beschreibung

Neoplasm Metastasis Evidence Biopsy | Measurable lesion metastatic Quantity | Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0005558
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0392920
received 1st and 2nd line chemotherapy
Beschreibung

Chemotherapy First line treatment | Chemotherapy Second line treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1708063
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1710038
hemoglobin (hb) <= 11g/dl at the time of randomization
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
planned to receive at least 2 more cycles of chemotherapy
Beschreibung

Chemotherapy cycle Quantity Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1301732
life expectancy > 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group score 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
at least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year
Beschreibung

Age | Contraceptive methods | Female Sterilization | Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0232970
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
active second cancer
Beschreibung

Second Primary Cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0751623
no recent history of clinically relevant thrombovascular event
Beschreibung

Thrombotic disorder Relevant Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040053
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
current treatment with anticoagulants
Beschreibung

Anticoagulants

Datentyp

boolean

Alias
UMLS CUI [1]
C0003280
brain metastasis or cns involvement
Beschreibung

Metastatic malignant neoplasm to brain | Central Nervous System Involvement

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C4050309
anemia secondary to another cause
Beschreibung

Anemia Secondary to Cause

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0015127
recent (within prior 1 months) use of an esa
Beschreibung

Erythropoiesis Stimulating Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C1959590
patient pregnant or breast feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
progressive disease during adjuvant/neoadjuvant chemotherapy
Beschreibung

Chemotherapy, Adjuvant | Neoadjuvant Chemotherapy | Progressive Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0392920
UMLS CUI [3]
C1335499
rapidly progressive or life-threatening metastatic disease
Beschreibung

Neoplasm Metastasis Rapidly progressive | Neoplasm Metastasis Life Threatening

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1838681
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C2826244
concomitant endocrine therapy
Beschreibung

Hormone Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279025
patient in whom the only site of metastasis was local and was successfully treated surgically.
Beschreibung

Neoplasm Metastasis Site Local | Neoplasm Metastasis Operative Surgical Procedure Successful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205276
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C1272703
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Ähnliche Modelle

Eligibility Breast Cancer NCT00338286

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Slide Breast tissue sample
Item
histologically confirmed (e.g., slide of tissue) breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C1705201 (UMLS CUI [1,2])
C0444070 (UMLS CUI [1,3])
HER2/Neu Positive | HER2/Neu Negative
Item
her2/neu positive or negative
boolean
C2348909 (UMLS CUI [1])
C2348908 (UMLS CUI [2])
Neoplasm Metastasis Evidence Biopsy | Measurable lesion metastatic Quantity | Chemotherapy
Item
clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (m1) lesion prior to starting the current chemotherapy
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3])
Chemotherapy First line treatment | Chemotherapy Second line treatment
Item
received 1st and 2nd line chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C1710038 (UMLS CUI [2,2])
Hemoglobin measurement
Item
hemoglobin (hb) <= 11g/dl at the time of randomization
boolean
C0518015 (UMLS CUI [1])
Chemotherapy cycle Quantity Planned
Item
planned to receive at least 2 more cycles of chemotherapy
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group score 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age | Contraceptive methods | Female Sterilization | Postmenopausal state
Item
at least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year
boolean
C0001779 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Second Primary Cancer
Item
active second cancer
boolean
C0751623 (UMLS CUI [1])
Thrombotic disorder Relevant Clinical
Item
no recent history of clinically relevant thrombovascular event
boolean
C0040053 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Anticoagulants
Item
current treatment with anticoagulants
boolean
C0003280 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Central Nervous System Involvement
Item
brain metastasis or cns involvement
boolean
C0220650 (UMLS CUI [1])
C4050309 (UMLS CUI [2])
Anemia Secondary to Cause
Item
anemia secondary to another cause
boolean
C0002871 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
Erythropoiesis Stimulating Agents
Item
recent (within prior 1 months) use of an esa
boolean
C1959590 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
patient pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy, Adjuvant | Neoadjuvant Chemotherapy | Progressive Disease
Item
progressive disease during adjuvant/neoadjuvant chemotherapy
boolean
C0085533 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1335499 (UMLS CUI [3])
Neoplasm Metastasis Rapidly progressive | Neoplasm Metastasis Life Threatening
Item
rapidly progressive or life-threatening metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C1838681 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
Hormone Therapy
Item
concomitant endocrine therapy
boolean
C0279025 (UMLS CUI [1])
Neoplasm Metastasis Site Local | Neoplasm Metastasis Operative Surgical Procedure Successful
Item
patient in whom the only site of metastasis was local and was successfully treated surgically.
boolean
C0027627 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C1272703 (UMLS CUI [2,3])
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