Thyroid Nodule Size Quantity
Item
patients must have histologically or cytologically confirmed at least 1 thyroid nodule that is greater than or equal to1 cm. but less than or equal to 4 cm measured in greatest dimension and confirmed by the laboratory of pathology, nci:
boolean
C0040137 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Biopsy of thyroid Indeterminate | BRAF V600E Mutation
Item
indeterminate thyroid biopsy per bethesda criteria with braf v600e mutation
boolean
C0193781 (UMLS CUI [1,1])
C0205258 (UMLS CUI [1,2])
C2698302 (UMLS CUI [2])
Papillary thyroid carcinoma Suspicious | Papillary thyroid carcinoma
Item
cytologically or histologically suspicious or confirmed ptc per bethesda criteria
boolean
C0238463 (UMLS CUI [1,1])
C0750493 (UMLS CUI [1,2])
C0238463 (UMLS CUI [2])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Children Excluded
Item
because ptc occurs rarely in patients < 18 years of age, children are excluded from this study.
boolean
C0008059 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Carcinoma Extension Absent Radiography
Item
absence of radiographic evidence of extrathyroidal extension.
boolean
C0007097 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0034571 (UMLS CUI [1,4])
Absence Lymphadenopathy Abnormal Physical Examination | Absence Lymphadenopathy Abnormal Imaging study | Absence Papillary thyroid carcinoma metastatic
Item
absence of abnormal lymphadenopathy suggesting metastatic ptc on physical examination and/or imaging studies.
boolean
C0332197 (UMLS CUI [1,1])
C0497156 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0497156 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
C1881134 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C0238463 (UMLS CUI [3,2])
C1522484 (UMLS CUI [3,3])
ECOG performance status
Item
ecog performance status less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Organ function | General Anesthesia | Thyroidectomy | Laboratory Results | Bone Marrow function | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Transaminase Assay | Chronic Kidney Diseases | Renal Replacement Therapy chronic | Pulmonary function tests | Diagnostic ultrasound of heart (echocardiogram) | Cardiac stress test
Item
patients must have adequate organ function to safely undergo general anesthesia and thyroidectomy. laboratory values obtained less than or equal to 4 weeks prior to surgery must demonstrate adequate bone marrow function (hb greater than or equal to 6.0 mmol/l, absolute neutrophil count greater than or equal to 1.5 x 109/l, platelets greater than or equal to 80 x 109/l), liver function (serum bilirubin less than or equal to 2 x uln, serum transaminases less than or equal to 3 x uln). patients with chronic kidney disease who are on chronic renal replacement therapy are allowed.. other tests, such as pulmonary function tests, cardiac echocardiogram or stress test, will be performed if clinically indicated.
boolean
C0678852 (UMLS CUI [1])
C0002915 (UMLS CUI [2])
C0040145 (UMLS CUI [3])
C1254595 (UMLS CUI [4])
C0005953 (UMLS CUI [5,1])
C0031843 (UMLS CUI [5,2])
C0518015 (UMLS CUI [6])
C0948762 (UMLS CUI [7])
C0032181 (UMLS CUI [8])
C0232741 (UMLS CUI [9])
C1278039 (UMLS CUI [10])
C0919834 (UMLS CUI [11])
C1561643 (UMLS CUI [12])
C0206074 (UMLS CUI [13,1])
C0205191 (UMLS CUI [13,2])
C0024119 (UMLS CUI [14])
C0810219 (UMLS CUI [15])
C0015260 (UMLS CUI [16])
Informed Consent
Item
ability of subject to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods
Item
pregnant women are eligible however women who are not pregnant at baseline must not become pregnant prior to surgery or during the first 3 months after surgery. women who can become pregnant will be asked to practice an effective form of birth control for up to 3 months after surgery, if they are not pregnant when they enter the study.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Operation on thyroid gland
Item
patients who have had previous thyroid surgery
boolean
C0193769 (UMLS CUI [1])
Thyroid carcinoma Concurrent | Hyperparathyroidism
Item
patients with concurrent thyroid cancer and hyperparathyroidism.
boolean
C0549473 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0020502 (UMLS CUI [2])
Unresectable Malignant Neoplasm
Item
patients whose tumors are deemed unresectable by clinical/imaging criteria.
boolean
C1336869 (UMLS CUI [1])
Distant metastasis Synchronous
Item
patients with known synchronous distant metastatic disease.
boolean
C1269798 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration
Item
patients with any active concurrent malignancy other than non-melanoma skin cancers or carcinoma-in situ of the cervix. patients with previous malignancies but without evidence of disease for > 5 years will be eligible.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
C0449238 (UMLS CUI [4,4])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])