ID

37787

Description

Imaging of ER Density to Guide and Improve Tailored Therapy for Acquired Anti-hormonal Resistant Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01088477

Link

https://clinicaltrials.gov/show/NCT01088477

Keywords

Versions (1)
  1. 8/24/19 8/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01088477

English

Eligibility Breast Cancer NCT01088477

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with the diagnosis of acquired anti-hormonal resistant advanced breast cancer showing progression after two or more lines of antihormonal treatment;
Description

Advanced breast cancer Resistant to Antihormone Therapy | Disease Progression | Status post Line of Antihormone Therapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3495917
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C2986607
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C4524693
UMLS CUI [3,3]
C2986607
UMLS CUI [3,4]
C1265611
2. treatment with estradiol will be started;
Description

Estradiol Medication starting

Data type

boolean

Alias
UMLS CUI [1,1]
C0014912
UMLS CUI [1,2]
C0451613
3. age> 18 years;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance status 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. life expectancy <3 months;
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
2. uncontrolled cns metastases;
Description

CNS metastases Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
3. history of thrombosis;
Description

Thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0040053
4. uncontrolled hypercalcemia;
Description

Hypercalcemia Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0205318
5. treatment with any investigational drug within 30 days before start of study;
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
6. serious uncontrolled concurrent illness, e.g. autoimmune disorders;
Description

Comorbidity Serious Uncontrolled | Autoimmune Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0004364
7. new york hearth association (nyha) class iii/iv congestive heart failure;
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
8. dyspnea at rest due to any cause;
Description

Resting Dyspnea Due to Cause Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0743330
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C1552551
9. pregnant or lactating women. documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause;
Description

Pregnancy | Breast Feeding | Premenopausal state Pregnancy test negative | Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0427780
10. women of childbearing potential unless a) surgically sterile or b) using adequate measures of contraception.
Description

Childbearing Potential | Exception Female Sterilization | Exception Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015787
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0700589
11. diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
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Similar models

Eligibility Breast Cancer NCT01088477

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Advanced breast cancer Resistant to Antihormone Therapy | Disease Progression | Status post Line of Antihormone Therapy Quantity
Item
1. patients with the diagnosis of acquired anti-hormonal resistant advanced breast cancer showing progression after two or more lines of antihormonal treatment;
boolean
C3495917 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C2986607 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C4524693 (UMLS CUI [3,2])
C2986607 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Estradiol Medication starting
Item
2. treatment with estradiol will be started;
boolean
C0014912 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
Age
Item
3. age> 18 years;
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Life Expectancy
Item
1. life expectancy <3 months;
boolean
C0023671 (UMLS CUI [1])
CNS metastases Uncontrolled
Item
2. uncontrolled cns metastases;
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Thrombosis
Item
3. history of thrombosis;
boolean
C0040053 (UMLS CUI [1])
Hypercalcemia Uncontrolled
Item
4. uncontrolled hypercalcemia;
boolean
C0020437 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Investigational New Drugs
Item
5. treatment with any investigational drug within 30 days before start of study;
boolean
C0013230 (UMLS CUI [1])
Comorbidity Serious Uncontrolled | Autoimmune Diseases
Item
6. serious uncontrolled concurrent illness, e.g. autoimmune disorders;
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0004364 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
7. new york hearth association (nyha) class iii/iv congestive heart failure;
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Resting Dyspnea Due to Cause Any
Item
8. dyspnea at rest due to any cause;
boolean
C0743330 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C1552551 (UMLS CUI [1,4])
Pregnancy | Breast Feeding | Premenopausal state Pregnancy test negative | Childbearing Potential Pregnancy test negative
Item
9. pregnant or lactating women. documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Childbearing Potential | Exception Female Sterilization | Exception Contraceptive methods
Item
10. women of childbearing potential unless a) surgically sterile or b) using adequate measures of contraception.
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015787 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Diabetes Mellitus
Item
11. diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
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