ID

36284

Description

Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in People With Low-risk Papillary Thyroid Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02408887

Link

https://clinicaltrials.gov/show/NCT02408887

Keywords

Versions (1)
  1. 4/29/19 4/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 29, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Low-risk Papillary Thyroid Cancer NCT02408887

English

Eligibility Low-risk Papillary Thyroid Cancer NCT02408887

1 forms  
Criteria
Description

Criteria

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:
Description

Thyroid Nodule Size Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0040137
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C1265611
indeterminate thyroid biopsy per bethesda criteria with braf v600e mutation
Description

Biopsy of thyroid Indeterminate | BRAF V600E Mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C0193781
UMLS CUI [1,2]
C0205258
UMLS CUI [2]
C2698302
cytologically or histologically suspicious or confirmed ptc per bethesda criteria
Description

Papillary thyroid carcinoma Suspicious | Papillary thyroid carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0238463
UMLS CUI [1,2]
C0750493
UMLS CUI [2]
C0238463
age > 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
because ptc occurs rarely in patients < 18 years of age, children are excluded from this study.
Description

Children Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C0332196
absence of radiographic evidence of extrathyroidal extension.
Description

Carcinoma Extension Absent Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C0231448
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C0034571
absence of abnormal lymphadenopathy suggesting metastatic ptc on physical examination and/or imaging studies.
Description

Absence Lymphadenopathy Abnormal Physical Examination | Absence Lymphadenopathy Abnormal Imaging study | Absence Papillary thyroid carcinoma metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0497156
UMLS CUI [1,3]
C0205161
UMLS CUI [1,4]
C0031809
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0497156
UMLS CUI [2,3]
C0205161
UMLS CUI [2,4]
C1881134
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0238463
UMLS CUI [3,3]
C1522484
ecog performance status less than or equal to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0002915
UMLS CUI [3]
C0040145
UMLS CUI [4]
C1254595
UMLS CUI [5,1]
C0005953
UMLS CUI [5,2]
C0031843
UMLS CUI [6]
C0518015
UMLS CUI [7]
C0948762
UMLS CUI [8]
C0032181
UMLS CUI [9]
C0232741
UMLS CUI [10]
C1278039
UMLS CUI [11]
C0919834
UMLS CUI [12]
C1561643
UMLS CUI [13,1]
C0206074
UMLS CUI [13,2]
C0205191
UMLS CUI [14]
C0024119
UMLS CUI [15]
C0810219
UMLS CUI [16]
C0015260
ability of subject to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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.
Description

Pregnancy | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have had previous thyroid surgery
Description

Operation on thyroid gland

Data type

boolean

Alias
UMLS CUI [1]
C0193769
patients with concurrent thyroid cancer and hyperparathyroidism.
Description

Thyroid carcinoma Concurrent | Hyperparathyroidism

Data type

boolean

Alias
UMLS CUI [1,1]
C0549473
UMLS CUI [1,2]
C0205420
UMLS CUI [2]
C0020502
patients whose tumors are deemed unresectable by clinical/imaging criteria.
Description

Unresectable Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C1336869
patients with known synchronous distant metastatic disease.
Description

Distant metastasis Synchronous

Data type

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0439580
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.
Description

Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0332296
UMLS CUI [4,4]
C0449238
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.
Description

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
Back to the top of the page

Similar models

Eligibility Low-risk Papillary Thyroid Cancer NCT02408887

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
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])
Item Group
C0680251 (UMLS CUI)
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial