ID

43058

Beschreibung

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

Stichworte

Versionen (1)
  1. 17.09.21 17.09.21 -
Rechteinhaber

University of Wisconsin, Madison National Cancer Institute (NCI)

Hochgeladen am

17. September 2021

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Eligibility Stage I Papillary Thyroid Cancer NCT02138214

Englisch

Eligibility Stage I Papillary Thyroid Cancer NCT02138214

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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
Beschreibung

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

Datentyp

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])
Beschreibung

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

Datentyp

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
Beschreibung

Ability to read and write in english

Datentyp

boolean

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

Exclusion Criteria

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

Largest diameter of papillary thyroid carcinoma on ultrasound

Datentyp

boolean

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

Previous operation on thyroid gland

Datentyp

boolean

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

Concurrent active malignancy other than papillary thyroid cancer

Datentyp

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
Beschreibung

Informed consent unable | Lacks decision making capacity

Datentyp

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
Beschreibung

Tumor stage

Datentyp

boolean

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

Pre-existing vocal cord paralysis

Datentyp

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)
Beschreibung

Chronic neurologic condition which affects voice or swallow

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Pregnancy

Datentyp

boolean

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

Not willing a radioactive iodine

Datentyp

boolean

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

Evidence of nodal involvement identified in the operating room

Datentyp

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
Beschreibung

Failure to confirm diagnosis of cancer

Datentyp

boolean

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

Eligibility Stage I Papillary Thyroid Cancer NCT02138214

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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