ID

14794

Description

A Phase 2 Randomized, Double-blind Trial Evaluating the Effects of Chloroquine in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02333890

Link

https://clinicaltrials.gov/show/NCT02333890

Keywords

Versions (1)
  1. 4/28/16 4/28/16 -
Uploaded on

April 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02333890

English

Eligibility Breast Cancer NCT02333890

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed histologically confirmed primary invasive breast cancer who is currently not undergoing any treatment while awaiting surgery in the next 2-6 weeks
Description

Invasive breast carcinoma | Therapeutic procedure | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0543467
tumour ≥ 1.5 cm by palpation or imaging
Description

Malignant Neoplasms | Palpation | Diagnostic Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0030247
UMLS CUI [3]
C0011923
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent for the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known metastatic breast cancer
Description

Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1]
C0278488
history of pre-existing known retinal or ocular pathology patient has only one functioning eye
Description

Retinal Diseases | Disorder of eye | Unqualified visual loss, one eye

Data type

boolean

Alias
UMLS CUI [1]
C0035309
UMLS CUI [2]
C0015397
UMLS CUI [3]
C0155066
abnormal hepatic function (serum ast or alt >3x upper limit of normal)
Description

Liver Dysfunction | AST serum level result | Serum Alanine Transaminase tests | Upper Limit of Normal

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0428341
UMLS CUI [3]
C0036828
UMLS CUI [4]
C1519815
currently on cq or hcq or has been on the drug within the past 3 months for other conditions
Description

Chloroquine | Hydroxychloroquine

Data type

boolean

Alias
UMLS CUI [1]
C0008269
UMLS CUI [2]
C0020336
known history of psoriasis
Description

Psoriasis

Data type

boolean

Alias
UMLS CUI [1]
C0033860
known history of epilepsy or seizures
Description

Epilepsy | Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0036572
electrocardiogram showing qt prolongation based on qtc interval >450 ms
Description

Electrocardiogram Prolonged QT interval QTc interval

Data type

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0151878
UMLS CUI [1,3]
C0489625
inability to comply with a study protocol (abuse of alcohol, drugs or psychotic states)
Description

Compliance behavior Limited | Substance Use Disorders | Pathological drug intoxication

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0152129
current known pregnancy or actively nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
allergic reactions to quinolones or cq
Description

Allergic Reaction Quinolones | Allergic Reaction Chloroquine

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0034428
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0008269
inability to consent.
Description

Unable Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0021430
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Similar models

Eligibility Breast Cancer NCT02333890

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive breast carcinoma | Therapeutic procedure | Operative Surgical Procedures
Item
newly diagnosed histologically confirmed primary invasive breast cancer who is currently not undergoing any treatment while awaiting surgery in the next 2-6 weeks
boolean
C0853879 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Malignant Neoplasms | Palpation | Diagnostic Imaging
Item
tumour ≥ 1.5 cm by palpation or imaging
boolean
C0006826 (UMLS CUI [1])
C0030247 (UMLS CUI [2])
C0011923 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
written informed consent for the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Carcinoma breast stage IV
Item
known metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
Retinal Diseases | Disorder of eye | Unqualified visual loss, one eye
Item
history of pre-existing known retinal or ocular pathology patient has only one functioning eye
boolean
C0035309 (UMLS CUI [1])
C0015397 (UMLS CUI [2])
C0155066 (UMLS CUI [3])
Liver Dysfunction | AST serum level result | Serum Alanine Transaminase tests | Upper Limit of Normal
Item
abnormal hepatic function (serum ast or alt >3x upper limit of normal)
boolean
C0086565 (UMLS CUI [1])
C0428341 (UMLS CUI [2])
C0036828 (UMLS CUI [3])
C1519815 (UMLS CUI [4])
Chloroquine | Hydroxychloroquine
Item
currently on cq or hcq or has been on the drug within the past 3 months for other conditions
boolean
C0008269 (UMLS CUI [1])
C0020336 (UMLS CUI [2])
Psoriasis
Item
known history of psoriasis
boolean
C0033860 (UMLS CUI [1])
Epilepsy | Seizures
Item
known history of epilepsy or seizures
boolean
C0014544 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Electrocardiogram Prolonged QT interval QTc interval
Item
electrocardiogram showing qt prolongation based on qtc interval >450 ms
boolean
C0013798 (UMLS CUI [1,1])
C0151878 (UMLS CUI [1,2])
C0489625 (UMLS CUI [1,3])
Compliance behavior Limited | Substance Use Disorders | Pathological drug intoxication
Item
inability to comply with a study protocol (abuse of alcohol, drugs or psychotic states)
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2])
C0152129 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
current known pregnancy or actively nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Allergic Reaction Quinolones | Allergic Reaction Chloroquine
Item
allergic reactions to quinolones or cq
boolean
C1527304 (UMLS CUI [1,1])
C0034428 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0008269 (UMLS CUI [2,2])
Unable Informed Consent
Item
inability to consent.
boolean
C1299582 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
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