Primary malignant neoplasm | Neoplasm Metastasis | Exception Melanoma | Exception Basal cell carcinoma | Exception Sarcoma | Exception Lymphoma
Item
participant must have histological confirmation of primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma.
boolean
C1306459 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0025202 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1261473 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0024299 (UMLS CUI [6,2])
Primary malignant neoplasm Diameter | Focus metastatic Diameter | Palpation | Ultrasonography | Mammography | CT | MRI
Item
primary tumor or metastatic focus must be 1.5cm or greater in diameter as established by palpation, ultrasound, mammography, ct or mri.
boolean
C1306459 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0205234 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0030247 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
C0024671 (UMLS CUI [5])
C0040405 (UMLS CUI [6])
C0024485 (UMLS CUI [7])
Age
Item
participant must be 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Primary malignant neoplasm Tumor tissue Available | Neoplasm Lesion Tumor tissue Available | HER2/Neu Status Immunohistochemistry | HER2/Neu Status FISH
Item
availability of tumor tissue (either from the initial primary tumor or from current tumor lesion) for performing ihc or fish analysis for her2/neu (erb2)
boolean
C1306459 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0475358 (UMLS CUI [2,3])
C0470187 (UMLS CUI [2,4])
C1512413 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C1512413 (UMLS CUI [4,1])
C0162789 (UMLS CUI [4,2])
Chemistry | Complete Blood Count | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Gilbert Disease | Platelet Count measurement
Item
chemistry and cbc parameters: serum creatinine less than or equal to 1.4mg/dl. sgot and sgpt less than or equal to 3 times of the upper limits of normal; total bilirubin, of less than or equal to 2 times the upper limits of normal or 3.0 mg/dl in patients with gilbert s syndrome; platelet count must be greater than 100,00.
boolean
C0151339 (UMLS CUI [1])
C0009555 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0017551 (UMLS CUI [7])
C0032181 (UMLS CUI [8])
ECOG performance status
Item
ecog performance score of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
ability to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Imaging Agent Injection | Childbearing Potential Contraceptive methods | Contraception, Barrier | Sexual Abstinence | Exception Hormonal contraception | Indium 111 Trastuzumab Injection
Item
negative serum pregnancy test (within 48 hours of imaging agent injection) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of (111)indium trastuzumab if participant is of child bearing age.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C1512628 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C2985296 (UMLS CUI [6,2])
C1881194 (UMLS CUI [7,1])
C1533685 (UMLS CUI [7,2])
Hypersensitivity trastuzumab
Item
known allergy to trastuzumab.
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Enrollment | Delay Standard therapy Scheduled
Item
participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy.
boolean
C1516879 (UMLS CUI [1])
C0205421 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
Second Cancer | Exception Basal cell carcinoma Treated
Item
participants with an active second malignancy (excluding treated basal cell skin carcinoma).
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Heart Diseases | Myocardial Infarction | Cardiac Arrhythmia Treatment required for | Valvular disease Symptomatic | Cardiomyopathy | Pericarditis
Item
history of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis).
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C3258293 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0878544 (UMLS CUI [5])
C0031046 (UMLS CUI [6])
Comorbidity Interferes with Clinical Trial Procedure | Comorbidity Interferes with Research results | Mental disorders Interfere with Clinical Trial Procedure | Mental disorders Interfere with Research results
Item
participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
C0184661 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
Claustrophobia Severe
Item
participants with severe claustrophobia.
boolean
C0008909 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Radionuclide Imaging Completed | Work up | Exception Positron-Emission Tomography
Item
a participant who needs a nuclear medicine scan other than a pet scan as part of their work-up cannot enroll until these scans have been completed.
boolean
C0034606 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0750430 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
Gamma Camera Scanning System Restriction | Body Weight Limited
Item
gamma-camera table restrictions preclude scanning participants greater than 350 lbs (160 kg)
boolean
C0810610 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Investigational New Drugs | Exception AT 13387 | Exception PU-H71 | Exception Autologous dendritic cell/adenovirus HER-2 vaccine
Item
with the exception of at13387 and pu-h71, and ad5f35her2ectm transduced autologous dendritic cell vaccine participants cannot have received another experimental drug within 14 days prior to or during study enrollment.
boolean
C0013230 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2830135 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3502086 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1831756 (UMLS CUI [4,2])