ID

43058

Description

Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02138214

Link

https://clinicaltrials.gov/show/NCT02138214

Keywords

  1. 9/17/21 9/17/21 -
Copyright Holder

University of Wisconsin, Madison National Cancer Institute (NCI)

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 4.0

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Eligibility Stage I Papillary Thyroid Cancer NCT02138214

Eligibility Stage I Papillary Thyroid Cancer NCT02138214

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (fna)
Description

Pre-operative diagnosis or suspicion of papillary thyroid cancer, fine needle aspiration

Data type

boolean

Alias
UMLS CUI [1,1]
C0238463
UMLS CUI [1,2]
C0750493
UMLS CUI [1,3]
C0445204
UMLS CUI [1,4]
C1510483
UMLS CUI [2,1]
C0238463
UMLS CUI [2,2]
C0011900
UMLS CUI [2,3]
C0445204
UMLS CUI [2,4]
C1510483
no pre-operative evidence of cervical lymph node metastases on neck ultrasound
Description

Absence of pre-operative evidence of cervical lymph node metastases on neck ultrasound

Data type

boolean

Alias
UMLS CUI [1,1]
C0588054
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0445204
UMLS CUI [1,4]
C1456803
UMLS CUI [1,5]
C0332120
UMLS CUI [1,6]
C0332197
no evidence of distant metastases (minimum of a negative complete x-ray [cxr])
Description

Absence of evidence of distant metastasis | Negative complete x-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C1269798
UMLS CUI [1,4]
C0039985
ability to read and write in english
Description

Ability to read and write in english

Data type

boolean

Alias
UMLS CUI [1,1]
C0376245
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0584993
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
largest papillary thyroid carcinoma < 1 cm in size on ultrasound
Description

Largest diameter of papillary thyroid carcinoma on ultrasound

Data type

boolean

Alias
UMLS CUI [1,1]
C0238463
UMLS CUI [1,2]
C0041618
UMLS CUI [1,3]
C1301886
previous thyroid surgery
Description

Previous operation on thyroid gland

Data type

boolean

Alias
UMLS CUI [1,1]
C0193769
UMLS CUI [1,2]
C0262926
concurrent active malignancy of another type
Description

Concurrent active malignancy other than papillary thyroid cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0238463
UMLS CUI [1,4]
C1705847
inability to give informed consent or lacks decision making capacity
Description

Informed consent unable | Lacks decision making capacity

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0011109
UMLS CUI [2,2]
C2698977
UMLS CUI [2,3]
C0332268
t4 tumor
Description

Tumor stage

Data type

boolean

Alias
UMLS CUI [1]
C0475455
pre-existing vocal cord paralysis
Description

Pre-existing vocal cord paralysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0042930
UMLS CUI [1,2]
C0522224
UMLS CUI [1,3]
C2347662
chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or parkinson disease)
Description

Chronic neurologic condition which affects voice or swallow

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205494
UMLS CUI [1,3]
C0205191
UMLS CUI [1,4]
C0392760
UMLS CUI [1,5]
C0042939
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205494
UMLS CUI [2,3]
C0205191
UMLS CUI [2,4]
C0392760
UMLS CUI [2,5]
C2712086
baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function
Description

Interventional procedure due to a laryngeal pathology that would affect voice or swallow function

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0023078
UMLS CUI [1,4]
C0030664
UMLS CUI [1,5]
C0392760
UMLS CUI [1,6]
C0042939
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0023078
UMLS CUI [2,4]
C0030664
UMLS CUI [2,5]
C0392760
UMLS CUI [2,6]
C0566355
becomes pregnant before surgery or at any time while on study
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
does not want radioactive iodine
Description

Not willing a radioactive iodine

Data type

boolean

Alias
UMLS CUI [1,1]
C0303029
UMLS CUI [1,2]
C0558080
evidence of nodal involvement identified in the operating room (or)
Description

Evidence of nodal involvement identified in the operating room

Data type

boolean

Alias
UMLS CUI [1,1]
C0441949
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0029064
UMLS CUI [1,4]
C0205396
failure to confirm diagnosis of cancer in participant
Description

Failure to confirm diagnosis of cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C1272705

Similar models

Eligibility Stage I Papillary Thyroid Cancer NCT02138214

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Pre-operative diagnosis or suspicion of papillary thyroid cancer, fine needle aspiration
Item
pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (fna)
boolean
C0238463 (UMLS CUI [1,1])
C0750493 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C1510483 (UMLS CUI [1,4])
C0238463 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0445204 (UMLS CUI [2,3])
C1510483 (UMLS CUI [2,4])
Absence of pre-operative evidence of cervical lymph node metastases on neck ultrasound
Item
no pre-operative evidence of cervical lymph node metastases on neck ultrasound
boolean
C0588054 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C1456803 (UMLS CUI [1,4])
C0332120 (UMLS CUI [1,5])
C0332197 (UMLS CUI [1,6])
Absence of evidence of distant metastasis | Negative complete x-ray
Item
no evidence of distant metastases (minimum of a negative complete x-ray [cxr])
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1269798 (UMLS CUI [1,3])
C0039985 (UMLS CUI [1,4])
Ability to read and write in english
Item
ability to read and write in english
boolean
C0376245 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0584993 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Largest diameter of papillary thyroid carcinoma on ultrasound
Item
largest papillary thyroid carcinoma < 1 cm in size on ultrasound
boolean
C0238463 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Previous operation on thyroid gland
Item
previous thyroid surgery
boolean
C0193769 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Concurrent active malignancy other than papillary thyroid cancer
Item
concurrent active malignancy of another type
boolean
C0006826 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0238463 (UMLS CUI [1,3])
C1705847 (UMLS CUI [1,4])
Informed consent unable | Lacks decision making capacity
Item
inability to give informed consent or lacks decision making capacity
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0011109 (UMLS CUI [2,1])
C2698977 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Tumor stage
Item
t4 tumor
boolean
C0475455 (UMLS CUI [1])
Pre-existing vocal cord paralysis
Item
pre-existing vocal cord paralysis
boolean
C0042930 (UMLS CUI [1,1])
C0522224 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
Chronic neurologic condition which affects voice or swallow
Item
chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or parkinson disease)
boolean
C0348080 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0042939 (UMLS CUI [1,5])
C0348080 (UMLS CUI [2,1])
C0205494 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0392760 (UMLS CUI [2,4])
C2712086 (UMLS CUI [2,5])
Interventional procedure due to a laryngeal pathology that would affect voice or swallow function
Item
baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function
boolean
C0184661 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0023078 (UMLS CUI [1,3])
C0030664 (UMLS CUI [1,4])
C0392760 (UMLS CUI [1,5])
C0042939 (UMLS CUI [1,6])
C0184661 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0023078 (UMLS CUI [2,3])
C0030664 (UMLS CUI [2,4])
C0392760 (UMLS CUI [2,5])
C0566355 (UMLS CUI [2,6])
Pregnancy
Item
becomes pregnant before surgery or at any time while on study
boolean
C0032961 (UMLS CUI [1])
Not willing a radioactive iodine
Item
does not want radioactive iodine
boolean
C0303029 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Evidence of nodal involvement identified in the operating room
Item
evidence of nodal involvement identified in the operating room (or)
boolean
C0441949 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0029064 (UMLS CUI [1,3])
C0205396 (UMLS CUI [1,4])
Failure to confirm diagnosis of cancer
Item
failure to confirm diagnosis of cancer in participant
boolean
C0006826 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])

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