ID

37974

Description

TPI 287 in Breast Cancer Metastatic to the Brain; ODM derived from: https://clinicaltrials.gov/show/NCT01332630

Lien

https://clinicaltrials.gov/show/NCT01332630

Mots-clés

Versions (1)
  1. 04/09/19 04/09/19 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

4 settembre 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01332630

Anglais

Eligibility Breast Cancer NCT01332630

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically proven breast cancer with metastatic disease to the brain.
Description

Breast Carcinoma | Metastatic malignant neoplasm to brain

Type de données

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0220650
2. patients must have measurable disease on mri that has progressed after prior therapy. pd will be defined as a>/= 25% increase in the sum of the products of greatest perpendicular diameters of all measurable disease over the smallest sum observed (since treatment started) on gd-mri, the appearance of new lesions on scan, or clinical or neurologic worsening despite stable disease on the last 2 scans.
Description

Measurable Disease MRI | Progressive Disease | Status post Prior Therapy | Measurable Disease Vertical diameter MRI gadolinium-enhanced | New Lesion Identification Scan | Worsening Clinical | Worsening Neurologic | Stable Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C1335499
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1514463
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C4067892
UMLS CUI [4,3]
C0855566
UMLS CUI [5,1]
C2986548
UMLS CUI [5,2]
C0441633
UMLS CUI [6,1]
C0332271
UMLS CUI [6,2]
C0205210
UMLS CUI [7,1]
C0332271
UMLS CUI [7,2]
C0205494
UMLS CUI [8]
C0677946
3. patients may have had any number of prior surgeries, radiation and/or chemotherapy regimens as adjuvant, neoadjuvant or palliative therapy for the treatment of their disease
Description

Operative Surgical Procedures Previous Quantity | Prior radiation therapy Quantity | Prior Chemotherapy Quantity | Adjuvant therapy Disease | Neoadjuvant Therapy Disease | Palliative Care Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C0012634
UMLS CUI [5,1]
C0600558
UMLS CUI [5,2]
C0012634
UMLS CUI [6,1]
C0030231
UMLS CUI [6,2]
C0012634
4. patients must be >/=18 years of age.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
5. patients must have an ecog performance status of 0,1 or 2.
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
6. patients must have adequate bone marrow function as evidenced by an absolute neutrophil count >/=1,500/microliters and a platelet count >/=100,000/microliter, adequate renal function as evidenced by serum creatinine </=2.0 mg/dl, adequate hepatic function as evidenced by serum total bilirubin </=2.0 mg/dl, ast/sgot and alt/sgpt </= 3x the uln.
Description

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Renal function | Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0201976
7. patients must have recovered and healed from the effects of any prior surgery, must have received prior chemotherapy at least 2 weeks prior to dosing with adequate recovery of wbc and platelet counts, and at least 12 weeks must have elapsed from the completion of radiotherapy, unless there are new lesions appearing on imaging within this 12 weeks frame.
Description

Effects of Operative Surgical Procedure Previous | Patient recovered | Prior Chemotherapy | Recovery White Blood Cell Count procedure | Recovery Platelet Count measurement | Therapeutic radiology procedure Completed | Exception New Lesion Identification Imaging

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704420
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0205156
UMLS CUI [2]
C1115804
UMLS CUI [3]
C1514457
UMLS CUI [4,1]
C0237820
UMLS CUI [4,2]
C0023508
UMLS CUI [5,1]
C0237820
UMLS CUI [5,2]
C0032181
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0205197
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C2986548
UMLS CUI [7,3]
C0011923
8. women of child-bearing potential (i.e. </= 50 years of age or has had menstrual cycle within the past 12 months, if > 50 years of age. if in doubt, check fsh, lh and estradiol level) must have a negative urine or serum pregnancy test at screening.
Description

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Age | Menstrual cycle | Follicle stimulating hormone measurement | Luteinizing hormone measurement | Estradiol measurement

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0025329
UMLS CUI [5]
C0202022
UMLS CUI [6]
C0202123
UMLS CUI [7]
C0337434
9. sexually active patients must agree to use adequate contraception (abstinence or barrier contraceptives must be used throughout the trial and one month after end of treatment) for the duration of the study .
Description

Patients Sexually active Contraceptive methods | Sexual Abstinence | Contraception, Barrier

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [2]
C0036899
UMLS CUI [3]
C0004764
10. patients or their legal representative must be able to read, understand and sign an informed consent form (icf).
Description

Informed Consent | Informed Consent Patient Representative

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
11. tpi 287 may interfere with coumadin dosing and patients who are taking this combination will require monitoring of their pt, ptt and inr.
Description

TPI-287 Interferes with Coumadin Dose | Requirement Monitoring Prothrombin time assay | Requirement Monitoring Activated Partial Thromboplastin Time measurement | Requirement Monitoring International Normalized Ratio

Type de données

boolean

Alias
UMLS CUI [1,1]
C1710314
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0699129
UMLS CUI [1,4]
C0178602
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0030695
UMLS CUI [2,3]
C0033707
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0030695
UMLS CUI [3,3]
C0030605
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0030695
UMLS CUI [4,3]
C0525032
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who are receiving concurrent enzyme-inducing anti-epileptic drugs (eiaeds) (e.g., carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital and primidone) or who received eiaeds within 2 weeks prior to the first dose of study drug.
Description

Antiepileptic Agents Inducing Enzymes | Carbamazepine | oxcarbazepine | Phenytoin | fosphenytoin | Phenobarbital | Primidone

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0205263
UMLS CUI [1,3]
C0014442
UMLS CUI [2]
C0006949
UMLS CUI [3]
C0069751
UMLS CUI [4]
C0031507
UMLS CUI [5]
C0244656
UMLS CUI [6]
C0031412
UMLS CUI [7]
C0033148
2. patients with uncontrolled intracranial hypertension syndrome (defined as: persistence of headache, transient visual obscurations, and/or diplopia despite optimal clinical management) or uncontrolled seizure activity (i.e. recorded despite optimal medical management).
Description

Intracranial Hypertension Uncontrolled | Persistent headache | Visual obscuration Transient | Diplopia | Disease Management Optimal | Seizure Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0151740
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0744648
UMLS CUI [3,1]
C1321318
UMLS CUI [3,2]
C0205374
UMLS CUI [4]
C0012569
UMLS CUI [5,1]
C0376636
UMLS CUI [5,2]
C2698651
UMLS CUI [6,1]
C0036572
UMLS CUI [6,2]
C0205318
3. patients who are not on a stable or decreasing steroid dose for the previous week prior to the first dose of study enrollment
Description

Steroids Dose Unstable | Steroids Dose Decreasing

Type de données

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0442797
4. patients who are taking bevacizumab or have taken bevacizumab within the past 2 weeks for treatment of their brain metastases
Description

bevacizumab | Therapeutic procedure Metastatic malignant neoplasm to brain

Type de données

boolean

Alias
UMLS CUI [1]
C0796392
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0220650
5. patients with an active infection (i.e., clinical signs or symptoms, including, but not limited to: bleeding/pustulant skin infections; productive cough associated with fever) on antibiotics or with a fever >/=38.5°c within 3 days prior to registration (i.e. date when the patient signs the consent and/or the patient is registered in core).
Description

Communicable Disease | Sign or Symptom Hemorrhage | Sign or Symptom Infectious Skin Diseases Pustules | Cough Associated with Fever | Antibiotics | Fever

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0019080
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C0037278
UMLS CUI [3,3]
C0241157
UMLS CUI [4,1]
C0010200
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0015967
UMLS CUI [5]
C0003232
UMLS CUI [6]
C0015967
6. patients with nyha class 3 or 4 congestive heart failure.
Description

Congestive heart failure New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
7. patients with known hiv or hepatitis b or c
Description

HIV Infection | Hepatitis B | Hepatitis C

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
8. patients who are pregnant or lactating or not practicing adequate contraception
Description

Pregnancy | Breast Feeding | Patients Contraceptive methods Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
9. patients with any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with the patient's ability to sign the icf or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results.
Description

Medical condition Interferes with Informed Consent | Medical condition Interferes with Compliance behavior | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Mental disorder Interferes with Informed Consent | Mental disorder Interferes with Compliance behavior | Mental disorder Interferes with Study Subject Participation Status | Mental disorder Interferes with Interpretation Research results | Substance Use Disorder Interferes with Informed Consent | Substance Use Disorder Interferes with Compliance behavior | Substance Use Disorder Interferes with Study Subject Participation Status | Substance Use Disorder Interferes with Interpretation Research results

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0459471
UMLS CUI [4,4]
C0683954
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0021430
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1321605
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C2348568
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0459471
UMLS CUI [8,4]
C0683954
UMLS CUI [9,1]
C0038586
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0021430
UMLS CUI [10,1]
C0038586
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C1321605
UMLS CUI [11,1]
C0038586
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C2348568
UMLS CUI [12,1]
C0038586
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0459471
UMLS CUI [12,4]
C0683954
10. patients who are receiving concomitant systemic therapy for breast cancer.
Description

Systemic therapy Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0678222
11. patients with leptomeningeal disease (lmd) or with a history of lmd will be excluded.
Description

Leptomeningeal disease

Type de données

boolean

Alias
UMLS CUI [1]
C0751297
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Similar models

Eligibility Breast Cancer NCT01332630

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Metastatic malignant neoplasm to brain
Item
1. patients must have histologically proven breast cancer with metastatic disease to the brain.
boolean
C0678222 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Measurable Disease MRI | Progressive Disease | Status post Prior Therapy | Measurable Disease Vertical diameter MRI gadolinium-enhanced | New Lesion Identification Scan | Worsening Clinical | Worsening Neurologic | Stable Disease
Item
2. patients must have measurable disease on mri that has progressed after prior therapy. pd will be defined as a>/= 25% increase in the sum of the products of greatest perpendicular diameters of all measurable disease over the smallest sum observed (since treatment started) on gd-mri, the appearance of new lesions on scan, or clinical or neurologic worsening despite stable disease on the last 2 scans.
boolean
C1513041 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4,1])
C4067892 (UMLS CUI [4,2])
C0855566 (UMLS CUI [4,3])
C2986548 (UMLS CUI [5,1])
C0441633 (UMLS CUI [5,2])
C0332271 (UMLS CUI [6,1])
C0205210 (UMLS CUI [6,2])
C0332271 (UMLS CUI [7,1])
C0205494 (UMLS CUI [7,2])
C0677946 (UMLS CUI [8])
Operative Surgical Procedures Previous Quantity | Prior radiation therapy Quantity | Prior Chemotherapy Quantity | Adjuvant therapy Disease | Neoadjuvant Therapy Disease | Palliative Care Disease
Item
3. patients may have had any number of prior surgeries, radiation and/or chemotherapy regimens as adjuvant, neoadjuvant or palliative therapy for the treatment of their disease
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0677850 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0600558 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0030231 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
Age
Item
4. patients must be >/=18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. patients must have an ecog performance status of 0,1 or 2.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Renal function | Creatinine measurement, serum
Item
6. patients must have adequate bone marrow function as evidenced by an absolute neutrophil count >/=1,500/microliters and a platelet count >/=100,000/microliter, adequate renal function as evidenced by serum creatinine </=2.0 mg/dl, adequate hepatic function as evidenced by serum total bilirubin </=2.0 mg/dl, ast/sgot and alt/sgpt </= 3x the uln.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Effects of Operative Surgical Procedure Previous | Patient recovered | Prior Chemotherapy | Recovery White Blood Cell Count procedure | Recovery Platelet Count measurement | Therapeutic radiology procedure Completed | Exception New Lesion Identification Imaging
Item
7. patients must have recovered and healed from the effects of any prior surgery, must have received prior chemotherapy at least 2 weeks prior to dosing with adequate recovery of wbc and platelet counts, and at least 12 weeks must have elapsed from the completion of radiotherapy, unless there are new lesions appearing on imaging within this 12 weeks frame.
boolean
C1704420 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2])
C1514457 (UMLS CUI [3])
C0237820 (UMLS CUI [4,1])
C0023508 (UMLS CUI [4,2])
C0237820 (UMLS CUI [5,1])
C0032181 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C0205197 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C2986548 (UMLS CUI [7,2])
C0011923 (UMLS CUI [7,3])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Age | Menstrual cycle | Follicle stimulating hormone measurement | Luteinizing hormone measurement | Estradiol measurement
Item
8. women of child-bearing potential (i.e. </= 50 years of age or has had menstrual cycle within the past 12 months, if > 50 years of age. if in doubt, check fsh, lh and estradiol level) must have a negative urine or serum pregnancy test at screening.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0025329 (UMLS CUI [4])
C0202022 (UMLS CUI [5])
C0202123 (UMLS CUI [6])
C0337434 (UMLS CUI [7])
Patients Sexually active Contraceptive methods | Sexual Abstinence | Contraception, Barrier
Item
9. sexually active patients must agree to use adequate contraception (abstinence or barrier contraceptives must be used throughout the trial and one month after end of treatment) for the duration of the study .
boolean
C0030705 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0036899 (UMLS CUI [2])
C0004764 (UMLS CUI [3])
Informed Consent | Informed Consent Patient Representative
Item
10. patients or their legal representative must be able to read, understand and sign an informed consent form (icf).
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
TPI-287 Interferes with Coumadin Dose | Requirement Monitoring Prothrombin time assay | Requirement Monitoring Activated Partial Thromboplastin Time measurement | Requirement Monitoring International Normalized Ratio
Item
11. tpi 287 may interfere with coumadin dosing and patients who are taking this combination will require monitoring of their pt, ptt and inr.
boolean
C1710314 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0699129 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1514873 (UMLS CUI [2,1])
C0030695 (UMLS CUI [2,2])
C0033707 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0030695 (UMLS CUI [3,2])
C0030605 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C0030695 (UMLS CUI [4,2])
C0525032 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Antiepileptic Agents Inducing Enzymes | Carbamazepine | oxcarbazepine | Phenytoin | fosphenytoin | Phenobarbital | Primidone
Item
1. patients who are receiving concurrent enzyme-inducing anti-epileptic drugs (eiaeds) (e.g., carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital and primidone) or who received eiaeds within 2 weeks prior to the first dose of study drug.
boolean
C0003299 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C0014442 (UMLS CUI [1,3])
C0006949 (UMLS CUI [2])
C0069751 (UMLS CUI [3])
C0031507 (UMLS CUI [4])
C0244656 (UMLS CUI [5])
C0031412 (UMLS CUI [6])
C0033148 (UMLS CUI [7])
Intracranial Hypertension Uncontrolled | Persistent headache | Visual obscuration Transient | Diplopia | Disease Management Optimal | Seizure Uncontrolled
Item
2. patients with uncontrolled intracranial hypertension syndrome (defined as: persistence of headache, transient visual obscurations, and/or diplopia despite optimal clinical management) or uncontrolled seizure activity (i.e. recorded despite optimal medical management).
boolean
C0151740 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0744648 (UMLS CUI [2])
C1321318 (UMLS CUI [3,1])
C0205374 (UMLS CUI [3,2])
C0012569 (UMLS CUI [4])
C0376636 (UMLS CUI [5,1])
C2698651 (UMLS CUI [5,2])
C0036572 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
Steroids Dose Unstable | Steroids Dose Decreasing
Item
3. patients who are not on a stable or decreasing steroid dose for the previous week prior to the first dose of study enrollment
boolean
C0038317 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0442797 (UMLS CUI [2,3])
bevacizumab | Therapeutic procedure Metastatic malignant neoplasm to brain
Item
4. patients who are taking bevacizumab or have taken bevacizumab within the past 2 weeks for treatment of their brain metastases
boolean
C0796392 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
Communicable Disease | Sign or Symptom Hemorrhage | Sign or Symptom Infectious Skin Diseases Pustules | Cough Associated with Fever | Antibiotics | Fever
Item
5. patients with an active infection (i.e., clinical signs or symptoms, including, but not limited to: bleeding/pustulant skin infections; productive cough associated with fever) on antibiotics or with a fever >/=38.5°c within 3 days prior to registration (i.e. date when the patient signs the consent and/or the patient is registered in core).
boolean
C0009450 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C3540840 (UMLS CUI [3,1])
C0037278 (UMLS CUI [3,2])
C0241157 (UMLS CUI [3,3])
C0010200 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0015967 (UMLS CUI [4,3])
C0003232 (UMLS CUI [5])
C0015967 (UMLS CUI [6])
Congestive heart failure New York Heart Association Classification
Item
6. patients with nyha class 3 or 4 congestive heart failure.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
HIV Infection | Hepatitis B | Hepatitis C
Item
7. patients with known hiv or hepatitis b or c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding | Patients Contraceptive methods Absent
Item
8. patients who are pregnant or lactating or not practicing adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Medical condition Interferes with Informed Consent | Medical condition Interferes with Compliance behavior | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Mental disorder Interferes with Informed Consent | Mental disorder Interferes with Compliance behavior | Mental disorder Interferes with Study Subject Participation Status | Mental disorder Interferes with Interpretation Research results | Substance Use Disorder Interferes with Informed Consent | Substance Use Disorder Interferes with Compliance behavior | Substance Use Disorder Interferes with Study Subject Participation Status | Substance Use Disorder Interferes with Interpretation Research results
Item
9. patients with any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with the patient's ability to sign the icf or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0021430 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1321605 (UMLS CUI [6,3])
C0004936 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0459471 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
C0038586 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0021430 (UMLS CUI [9,3])
C0038586 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C1321605 (UMLS CUI [10,3])
C0038586 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C2348568 (UMLS CUI [11,3])
C0038586 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
Systemic therapy Breast Carcinoma
Item
10. patients who are receiving concomitant systemic therapy for breast cancer.
boolean
C1515119 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Leptomeningeal disease
Item
11. patients with leptomeningeal disease (lmd) or with a history of lmd will be excluded.
boolean
C0751297 (UMLS CUI [1])
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