ID

19670

Description

A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00263211

Link

https://clinicaltrials.gov/show/NCT00263211

Keywords

Versions (1)
  1. 1/21/17 1/21/17 -
Uploaded on

January 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00263211

English

Eligibility Breast Neoplasms NCT00263211

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with metastatic breast cancer who are completing planned course of chemotherapy with planned treatment break
Description

Gender | Secondary malignant neoplasm of female breast | Chemotherapy Regimen Planned Completed | Therapeutic procedure Discontinue Planned

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0346993
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1301732
UMLS CUI [3,3]
C0205197
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C1444662
UMLS CUI [4,3]
C1301732
on stable hormone therapy for at least 2 months are also eligible for the study
Description

Hormone Therapy Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0205360
estimated survival of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
no platelet inhibitor therapy within 1 month of study entry
Description

Platelet Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0032188
platelets >= 100,000
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
coagulation screening tests within normal range (inr between 0.81 and 1.20)
Description

Blood coagulation screening test Normal Range International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1,1]
C3516413
UMLS CUI [1,2]
C0086715
UMLS CUI [1,3]
C0525032
normal kidney and liver function as defined by:
Description

Normal renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232805
UMLS CUI [2]
C0232741
ast/alt <= 2 x institutional normal
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinine <= 2 x institutional normal
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
able to provide signed, informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients going on to surgery
Description

Operative Surgical Procedure Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
patients with a serious bleeding disorder that make them inappropriate candidates for nsaid therapy
Description

Blood Coagulation Disorder Serious | Patients Inappropriate Non-Steroidal Anti-Inflammatory Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0003211
patients with history of significant bleeding related to peptic ulcer disease
Description

Hemorrhage Significant Peptic Ulcer Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0030920
UMLS CUI [1,4]
C0439849
patients on standing doses of nsaids or platelet function inhibitors
Description

Non-Steroidal Anti-Inflammatory Agents Dose Stable | Platelet Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0032188
patients on standing doses of anti-coagulants
Description

Anticoagulants Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0003280
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
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Similar models

Eligibility Breast Neoplasms NCT00263211

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Secondary malignant neoplasm of female breast | Chemotherapy Regimen Planned Completed | Therapeutic procedure Discontinue Planned
Item
women with metastatic breast cancer who are completing planned course of chemotherapy with planned treatment break
boolean
C0079399 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
Hormone Therapy Stable
Item
on stable hormone therapy for at least 2 months are also eligible for the study
boolean
C0279025 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Life Expectancy
Item
estimated survival of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Platelet Inhibitors
Item
no platelet inhibitor therapy within 1 month of study entry
boolean
C0032188 (UMLS CUI [1])
Platelet Count measurement
Item
platelets >= 100,000
boolean
C0032181 (UMLS CUI [1])
Blood coagulation screening test Normal Range International Normalized Ratio
Item
coagulation screening tests within normal range (inr between 0.81 and 1.20)
boolean
C3516413 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0525032 (UMLS CUI [1,3])
Normal renal function | Liver function
Item
normal kidney and liver function as defined by:
boolean
C0232805 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast/alt <= 2 x institutional normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
creatinine <= 2 x institutional normal
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
able to provide signed, informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Operative Surgical Procedure Planned
Item
patients going on to surgery
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Blood Coagulation Disorder Serious | Patients Inappropriate Non-Steroidal Anti-Inflammatory Agents
Item
patients with a serious bleeding disorder that make them inappropriate candidates for nsaid therapy
boolean
C0005779 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0003211 (UMLS CUI [2,3])
Hemorrhage Significant Peptic Ulcer Related
Item
patients with history of significant bleeding related to peptic ulcer disease
boolean
C0019080 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0030920 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
Non-Steroidal Anti-Inflammatory Agents Dose Stable | Platelet Inhibitors
Item
patients on standing doses of nsaids or platelet function inhibitors
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0032188 (UMLS CUI [2])
Anticoagulants Dose Stable
Item
patients on standing doses of anti-coagulants
boolean
C0003280 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
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