ID

31548

Description

Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01083550 Sponsor: University Health Network, Toronto Collaborators: Ontario Ministry of Health and Long Term Care Canadian Institutes of Health Research (CIHR) Information provided by (Responsible Party): University Health Network, Toronto Principal Investigator: Annie M Sawka, MD, PhD University Health Network, Toronto Study Director: David P Goldstein, MD University Health Network, Toronto

Link

https://clinicaltrials.gov/show/NCT01083550

Keywords

  1. 9/3/18 9/3/18 -
Copyright Holder

University Health Network, Toronto

Uploaded on

September 3, 2018

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Thyroid Cancer NCT01083550

Eligibility Thyroid Cancer NCT01083550

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
individuals with papillary thyroid carcinoma who have had complete resection of their thyroid at surgery (total or near-total thyroidectomy, or hemi- [subtotal] with completion thyroidectomy)on or after september 1, 2009
Description

Thyreoidectomy for papillary thyroid cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0238463
UMLS CUI [1,2]
C3709323
age at time of first thyroid cancer surgery must be at least 18 years or older
Description

Age at time of first thyroid cancer surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0007115
the papillary thyroid cancer tnm pathologic stage must be pt1 or pt2, n0 (or nx), m0 (or mx) (tnm stage, ajcc vi) (ie. primary tumor size 1-4 cm, no known positive lymph nodes at the time of primary surgery, no extension of the tumor outside the thyroid, no venous or lymphatic invasion, and no known distant metastases at primary surgery, with no tall cell features, as per surgical pathology report)
Description

TNM clinical staging of thyroid cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0007115
must be able to communicate in spoken and written english
Description

Written and spoken communication skills in English

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0376245
UMLS CUI [3,2]
C0584993
must be able to use a computer
Description

Ability to use a computer

Data type

boolean

Alias
UMLS CUI [1,1]
C3842632
UMLS CUI [1,2]
C0085732
must be able to provide informed consent on one's own (without any need for translation)
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria for Patient Participants
Description

Exclusion Criteria for Patient Participants

Alias
UMLS CUI-1
C0680251
participants not meeting inclusion criteria
Description

Not meeting inclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0231175
concurrent diagnosis of medullary or anaplastic or poorly differentiated thyroid cancer or thyroid lymphoma
Description

Concurrent diagnosis of other thyroid tumor types

Data type

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C0238462
UMLS CUI [2,1]
C0205420
UMLS CUI [2,2]
C0238461
UMLS CUI [3,1]
C0205420
UMLS CUI [3,2]
C1336753
UMLS CUI [4,1]
C0205420
UMLS CUI [4,2]
C1266050
prior radioactive treatment for thyroid cancer
Description

Prior radioactive treatment for thyroid cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0436252
UMLS CUI [1,3]
C0007115
individuals who have been taken off their thyroid hormone for testing or treatment, will not be eligible for the study while off this medication.
Description

Thyroid hormone replacement therapy pause

Data type

boolean

Alias
UMLS CUI [1,1]
C2242640
UMLS CUI [1,2]
C1550010
individuals who are unwilling for investigators to confirm their pathologic stage of disease through review of pathology report(s) will be ineligible for the study
Description

No Access to pathology reports

Data type

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0807321
Inclusion Criteria for Physicians
Description

Inclusion Criteria for Physicians

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0031831
physicians and surgeons caring for thyroid cancer patients, in active practice at university health network in toronto, ontario, canada.
Description

Physicians and surgeons caring for thyroid cancer patients at university health network in Toronto, Ontario, Canada

Data type

boolean

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0007115
UMLS CUI [1,3]
C2825164
UMLS CUI [2,1]
C0582175
UMLS CUI [2,2]
C0007115
UMLS CUI [2,3]
C2825164

Similar models

Eligibility Thyroid Cancer NCT01083550

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Thyreoidectomy for papillary thyroid cancer
Item
individuals with papillary thyroid carcinoma who have had complete resection of their thyroid at surgery (total or near-total thyroidectomy, or hemi- [subtotal] with completion thyroidectomy)on or after september 1, 2009
boolean
C0238463 (UMLS CUI [1,1])
C3709323 (UMLS CUI [1,2])
Age at time of first thyroid cancer surgery
Item
age at time of first thyroid cancer surgery must be at least 18 years or older
boolean
C0543467 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0007115 (UMLS CUI [1,3])
TNM clinical staging of thyroid cancer
Item
the papillary thyroid cancer tnm pathologic stage must be pt1 or pt2, n0 (or nx), m0 (or mx) (tnm stage, ajcc vi) (ie. primary tumor size 1-4 cm, no known positive lymph nodes at the time of primary surgery, no extension of the tumor outside the thyroid, no venous or lymphatic invasion, and no known distant metastases at primary surgery, with no tall cell features, as per surgical pathology report)
boolean
C3258246 (UMLS CUI [1,1])
C0007115 (UMLS CUI [1,2])
Written and spoken communication skills in English
Item
must be able to communicate in spoken and written english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0376245 (UMLS CUI [3,1])
C0584993 (UMLS CUI [3,2])
Ability to use a computer
Item
must be able to use a computer
boolean
C3842632 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Informed consent
Item
must be able to provide informed consent on one's own (without any need for translation)
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria for Patient Participants
C0680251 (UMLS CUI-1)
Not meeting inclusion criteria
Item
participants not meeting inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Concurrent diagnosis of other thyroid tumor types
Item
concurrent diagnosis of medullary or anaplastic or poorly differentiated thyroid cancer or thyroid lymphoma
boolean
C0205420 (UMLS CUI [1,1])
C0238462 (UMLS CUI [1,2])
C0205420 (UMLS CUI [2,1])
C0238461 (UMLS CUI [2,2])
C0205420 (UMLS CUI [3,1])
C1336753 (UMLS CUI [3,2])
C0205420 (UMLS CUI [4,1])
C1266050 (UMLS CUI [4,2])
Prior radioactive treatment for thyroid cancer
Item
prior radioactive treatment for thyroid cancer
boolean
C1514463 (UMLS CUI [1,1])
C0436252 (UMLS CUI [1,2])
C0007115 (UMLS CUI [1,3])
Thyroid hormone replacement therapy pause
Item
individuals who have been taken off their thyroid hormone for testing or treatment, will not be eligible for the study while off this medication.
boolean
C2242640 (UMLS CUI [1,1])
C1550010 (UMLS CUI [1,2])
No Access to pathology reports
Item
individuals who are unwilling for investigators to confirm their pathologic stage of disease through review of pathology report(s) will be ineligible for the study
boolean
C0444454 (UMLS CUI [1,1])
C0807321 (UMLS CUI [1,2])
Item Group
Inclusion Criteria for Physicians
C1512693 (UMLS CUI-1)
C0031831 (UMLS CUI-2)
Physicians and surgeons caring for thyroid cancer patients at university health network in Toronto, Ontario, Canada
Item
physicians and surgeons caring for thyroid cancer patients, in active practice at university health network in toronto, ontario, canada.
boolean
C0031831 (UMLS CUI [1,1])
C0007115 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
C0582175 (UMLS CUI [2,1])
C0007115 (UMLS CUI [2,2])
C2825164 (UMLS CUI [2,3])

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