ID

38184

Description

PREDATOR: Neoadjuvant Gene Prediction for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02067416

Link

https://clinicaltrials.gov/show/NCT02067416

Keywords

Versions (1)
  1. 9/25/19 9/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 25, 2019

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02067416

English

Eligibility Breast Cancer NCT02067416

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with histologic confirmation of invasive breast carcinoma.
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
2. patients must have intact primary tumor.
Description

Primary tumor Intact

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0205266
3. ≥18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. patients with bilateral breast cancer are eligible.
Description

Bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
5. patients with second primary breast cancers are eligible.
Description

Breast Carcinoma Primary second

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0205436
6. the primary breast tumor must be ≥ 2 cm by physical exam or imaging.
Description

Breast Carcinoma Primary Size Physical Examination | Breast Carcinoma Primary Size Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0456389
UMLS CUI [1,4]
C0031809
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C0456389
UMLS CUI [2,4]
C0011923
7. the tumor must have been determined to be her2-negative as follows:
Description

Neoplasm HER2 Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2348908
fluorescent in situ hybridization (fish)-negative (defined by ratio of her2 to cep17 must be < 2.2)
Description

FISH Negative | HER2/CEP17 Ratio

Data type

boolean

Alias
UMLS CUI [1,1]
C0162789
UMLS CUI [1,2]
C1513916
UMLS CUI [2]
C1977461
immunohistochemistry (ihc) 0-1+; or
Description

Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1]
C0021044
ihc 2+ and fish-negative
Description

Immunohistochemistry | FISH Negative

Data type

boolean

Alias
UMLS CUI [1]
C0021044
UMLS CUI [2,1]
C0162789
UMLS CUI [2,2]
C1513916
8. ecog ps of 0, 1, or 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
9. negative serum pregnancy test ≤7 days of treatment initiation and a serum or urine pregnancy test must be repeated ≤ 3 days prior to starting treatment for women of childbearing potential (wocbp). for wocbp, adequate contraception must be used throughout the study. for this study, acceptable methods of contraception include a reliable intrauterine device or a spermicide in combination with a barrier method. women who are already on hormonal forms of birth control may continue that treatment but must also use a barrier method.
Description

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Serum pregnancy test Repeated | Childbearing Potential Urine pregnancy test Repeated | Childbearing Potential Contraceptive methods | Intrauterine Devices | Vaginal Spermicides | Contraception, Barrier | Hormonal contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430064
UMLS CUI [2,3]
C0205341
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430056
UMLS CUI [3,3]
C0205341
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0087145
UMLS CUI [7]
C0004764
UMLS CUI [8]
C2985296
10. ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
Description

Comprehension Study Protocol | Informed Consent | Authorization Health information | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0680281
UMLS CUI [3,2]
C0850397
UMLS CUI [4]
C0525058
11. patient must be willing to undergo breast biopsies as required by the study protocol.
Description

Biopsy of breast

Data type

boolean

Alias
UMLS CUI [1]
C0405352
12. sufficient tissue must be available from the diagnostic core biopsies. if not, patients must undergo additional biopsies to perform mammostrat.
Description

Tissue specimen Sufficient Core needle biopsy | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C1318309
UMLS CUI [2]
C3846158
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.
Description

Cancer Other Invasive Treated | Exception Skin carcinoma | Exception Cervical cancer Non-invasive

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C4048328
UMLS CUI [3,3]
C0205303
2. prior treatment with any investigational drug within the preceding 4 weeks.
Description

Prior Therapy | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0013230
3. evidence of new york heart association class iii or greater cardiac disease.
Description

Heart Disease New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
4. history of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 6 months.
Description

Myocardial Infarction | Cerebrovascular accident | Ventricular arrhythmia | Cardiac conduction abnormality Symptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0085612
UMLS CUI [4,1]
C1842820
UMLS CUI [4,2]
C0231220
5. concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure or major surgery) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
Description

Comorbidity Severe | Comorbidity Uncontrolled | Sepsis | Diabetes Mellitus | Hypertensive disease | Coronary Artery Disease | Congestive heart failure | Major surgery | Comorbidity compromises Patient safety | Comorbidity compromises Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0243026
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0020538
UMLS CUI [6]
C1956346
UMLS CUI [7]
C0018802
UMLS CUI [8]
C0679637
UMLS CUI [9,1]
C0009488
UMLS CUI [9,2]
C2945640
UMLS CUI [9,3]
C1113679
UMLS CUI [10,1]
C0009488
UMLS CUI [10,2]
C2945640
UMLS CUI [10,3]
C2732579
6. pregnant or nursing women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. known allergic reaction to cremophor or any of the chemo agents on this trial.
Description

Allergic Reaction Cremophor | Allergic Reaction Chemicals Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0056475
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0220806
UMLS CUI [2,3]
C0008976
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Similar models

Eligibility Breast Cancer NCT02067416

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
1. patients with histologic confirmation of invasive breast carcinoma.
boolean
C0853879 (UMLS CUI [1])
Primary tumor Intact
Item
2. patients must have intact primary tumor.
boolean
C0677930 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
Age
Item
3. ≥18 years of age.
boolean
C0001779 (UMLS CUI [1])
Bilateral breast cancer
Item
4. patients with bilateral breast cancer are eligible.
boolean
C0281267 (UMLS CUI [1])
Breast Carcinoma Primary second
Item
5. patients with second primary breast cancers are eligible.
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
Breast Carcinoma Primary Size Physical Examination | Breast Carcinoma Primary Size Imaging
Item
6. the primary breast tumor must be ≥ 2 cm by physical exam or imaging.
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,4])
C0678222 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
C0011923 (UMLS CUI [2,4])
Neoplasm HER2 Negative
Item
7. the tumor must have been determined to be her2-negative as follows:
boolean
C0027651 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
FISH Negative | HER2/CEP17 Ratio
Item
fluorescent in situ hybridization (fish)-negative (defined by ratio of her2 to cep17 must be < 2.2)
boolean
C0162789 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1977461 (UMLS CUI [2])
Immunohistochemistry
Item
immunohistochemistry (ihc) 0-1+; or
boolean
C0021044 (UMLS CUI [1])
Immunohistochemistry | FISH Negative
Item
ihc 2+ and fish-negative
boolean
C0021044 (UMLS CUI [1])
C0162789 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
ECOG performance status
Item
8. ecog ps of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Serum pregnancy test Repeated | Childbearing Potential Urine pregnancy test Repeated | Childbearing Potential Contraceptive methods | Intrauterine Devices | Vaginal Spermicides | Contraception, Barrier | Hormonal contraception
Item
9. negative serum pregnancy test ≤7 days of treatment initiation and a serum or urine pregnancy test must be repeated ≤ 3 days prior to starting treatment for women of childbearing potential (wocbp). for wocbp, adequate contraception must be used throughout the study. for this study, acceptable methods of contraception include a reliable intrauterine device or a spermicide in combination with a barrier method. women who are already on hormonal forms of birth control may continue that treatment but must also use a barrier method.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430064 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0430056 (UMLS CUI [3,2])
C0205341 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0021900 (UMLS CUI [5])
C0087145 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C2985296 (UMLS CUI [8])
Comprehension Study Protocol | Informed Consent | Authorization Health information | Protocol Compliance
Item
10. ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0680281 (UMLS CUI [3,1])
C0850397 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4])
Biopsy of breast
Item
11. patient must be willing to undergo breast biopsies as required by the study protocol.
boolean
C0405352 (UMLS CUI [1])
Tissue specimen Sufficient Core needle biopsy | Other Coding
Item
12. sufficient tissue must be available from the diagnostic core biopsies. if not, patients must undergo additional biopsies to perform mammostrat.
boolean
C1292533 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C1318309 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Cancer Other Invasive Treated | Exception Skin carcinoma | Exception Cervical cancer Non-invasive
Item
1. patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.
boolean
C1707251 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C4048328 (UMLS CUI [3,2])
C0205303 (UMLS CUI [3,3])
Prior Therapy | Investigational New Drugs
Item
2. prior treatment with any investigational drug within the preceding 4 weeks.
boolean
C1514463 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Heart Disease New York Heart Association Classification
Item
3. evidence of new york heart association class iii or greater cardiac disease.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction | Cerebrovascular accident | Ventricular arrhythmia | Cardiac conduction abnormality Symptomatic
Item
4. history of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 6 months.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0085612 (UMLS CUI [3])
C1842820 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Comorbidity Severe | Comorbidity Uncontrolled | Sepsis | Diabetes Mellitus | Hypertensive disease | Coronary Artery Disease | Congestive heart failure | Major surgery | Comorbidity compromises Patient safety | Comorbidity compromises Completion of clinical trial
Item
5. concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure or major surgery) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0243026 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0020538 (UMLS CUI [5])
C1956346 (UMLS CUI [6])
C0018802 (UMLS CUI [7])
C0679637 (UMLS CUI [8])
C0009488 (UMLS CUI [9,1])
C2945640 (UMLS CUI [9,2])
C1113679 (UMLS CUI [9,3])
C0009488 (UMLS CUI [10,1])
C2945640 (UMLS CUI [10,2])
C2732579 (UMLS CUI [10,3])
Pregnancy | Breast Feeding
Item
6. pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Allergic Reaction Cremophor | Allergic Reaction Chemicals Clinical Trial
Item
7. known allergic reaction to cremophor or any of the chemo agents on this trial.
boolean
C1527304 (UMLS CUI [1,1])
C0056475 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0220806 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
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