ID

4574

Description

The trial examines the clinical benefit of adjuvant external beam radiotherapy (RTx) for locally invasive differentiated carcinoma (TNM stages pT4 pN0/1/x M0/x; 5th ed. 1997) of the thyroid gland (DTC). Patients are treated with surgery (thyroidectomy and lymphadenectomy), radioiodine therapy (RIT) to ablate the thyroid remnant tissue, and TSH-suppressive L-thyroxine therapy with or without RTx after documented elimination of cervical I-131 uptake.

Keywords

Versions (1)
  1. 12/11/13 12/11/13 - Martin Dugas
Uploaded on

December 11, 2013

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
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 NCT00144079 # Thyroid Carcinoma

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Description

Inclusion criteria

18 Years to 69 Years
Description

Age

Data type

boolean

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
No Healthy Volunteers
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI
C1708335
papillary or follicular thyroid carcinoma pT4 pN0/1/x M0/x
Description

InclusionCriterion_1

Data type

boolean

Alias
UMLS CUI
C0238463
MDR
10033701
SNOMED CT 2010_0731
255029007
UMLS CUI
C0206682
MDR
10016935
SNOMED CT 2010_0731
255028004
UMLS CUI
C0332394
SNOMED CT 2010_0731
6123003
completion of primary surgical therapy with R0 (no tumor residues) or R1 (microscopic residues) resection
Description

InclusionCriterion_2

Data type

boolean

Alias
UMLS CUI
C0920424
Karnofsky index > 70 %
Description

InclusionCriterion_3

Data type

boolean

Alias
UMLS CUI
C0206065
MDR
10054755
SNOMED CT 2010_0731
273546003
freedom from distant metastases at the time of initial radioiodine therapy
Description

InclusionCriterion_4

Data type

boolean

Alias
UMLS CUI
C0027627
ICD10CM
C79.9
MDR
10061289
SNOMED CT 2010_0731
128462008
UMLS CUI
C0475093
SNOMED CT 2010_0731
169342009
informed patient consent
Description

InclusionCriterion_5

Data type

boolean

Alias
UMLS CUI
C0021430
Exclusion criteria
Description

Exclusion criteria

secondary malignancy except basalioma
Description

ExclusionCriterion_1

Data type

boolean

Alias
UMLS CUI
C0865024
UMLS CUI
C0007117
MDR
10004146
SNOMED CT 2010_0731
254701007
pregnancy
Description

ExclusionCriterion_2

Data type

boolean

Alias
UMLS CUI
C0549206
MDR
10036586
SNOMED CT 2010_0731
77386006
serious general disease
Description

ExclusionCriterion_3

Data type

boolean

Alias
UMLS CUI
C0012634
SNOMED CT 2010_0731
64572001
serious psychiatric disorder
Description

ExclusionCriterion_4

Data type

boolean

Alias
UMLS CUI
C0004936
ICD10CM
F01-F99
ICD9CM
290-319.99
MDR
10061284
SNOMED CT 2010_0731
74732009
inability to give informed consent
Description

ExclusionCriterion_5

Data type

boolean

Alias
UMLS CUI
C0021430
previous RTx
Description

ExclusionCriterion_6

Data type

boolean

Alias
UMLS CUI
C1522449
MDR
10037794
SNOMED CT 2010_0731
108290001
recurrence of previous thyroid cancer
Description

ExclusionCriterion_7

Data type

boolean

Alias
UMLS CUI
C0278861
Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Healthy Subject
Description

Healthy Subject

Data type

string

Alias
UMLS CUI
C1708335
Papillary thyroid carcinoma
Description

Papillary thyroid carcinoma

Data type

string

Alias
UMLS CUI
C0238463
MDR
10033701
SNOMED CT 2010_0731
255029007
Follicular thyroid carcinoma
Description

Follicular thyroid carcinoma

Data type

string

Alias
UMLS CUI
C0206682
MDR
10016935
SNOMED CT 2010_0731
255028004
pT4 Stage Finding
Description

pT4 Stage Finding

Data type

string

Alias
UMLS CUI
C0332394
SNOMED CT 2010_0731
6123003
cancer surgery
Description

cancer surgery

Data type

string

Alias
UMLS CUI
C0920424
Karnofsky Performance Status
Description

Karnofsky Performance Status

Data type

string

Alias
UMLS CUI
C0206065
MDR
10054755
SNOMED CT 2010_0731
273546003
Neoplasm Metastasis
Description

Neoplasm Metastasis

Data type

string

Alias
UMLS CUI
C0027627
ICD10CM
C79.9
MDR
10061289
SNOMED CT 2010_0731
128462008
Thyroid tumor/metastasis irradiation
Description

Thyroid tumor/metastasis irradiation

Data type

string

Alias
UMLS CUI
C0475093
SNOMED CT 2010_0731
169342009
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Secondary malignancy, unspecified site
Description

Secondary malignancy, unspecified site

Data type

string

Alias
UMLS CUI
C0865024
Basal cell carcinoma
Description

Basal cell carcinoma

Data type

string

Alias
UMLS CUI
C0007117
MDR
10004146
SNOMED CT 2010_0731
254701007
Patient currently pregnant
Description

Patient currently pregnant

Data type

string

Alias
UMLS CUI
C0549206
MDR
10036586
SNOMED CT 2010_0731
77386006
Disease
Description

Disease

Data type

string

Alias
UMLS CUI
C0012634
SNOMED CT 2010_0731
64572001
Mental disorders
Description

Mental disorders

Data type

string

Alias
UMLS CUI
C0004936
ICD10CM
F01-F99
ICD9CM
290-319.99
MDR
10061284
SNOMED CT 2010_0731
74732009
Therapeutic radiology procedure
Description

Therapeutic radiology procedure

Data type

string

Alias
UMLS CUI
C1522449
MDR
10037794
SNOMED CT 2010_0731
108290001
Recurrent Thyroid Gland Carcinoma
Description

Recurrent Thyroid Gland Carcinoma

Data type

string

Alias
UMLS CUI
C0278861
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
Age
Item
18 Years to 69 Years
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Healthy Volunteers
Item
No Healthy Volunteers
boolean
C1708335 (UMLS CUI)
InclusionCriterion_1
Item
papillary or follicular thyroid carcinoma pT4 pN0/1/x M0/x
boolean
C0238463 (UMLS CUI)
10033701 (MDR)
255029007 (SNOMED CT 2010_0731)
C0206682 (UMLS CUI)
10016935 (MDR)
255028004 (SNOMED CT 2010_0731)
C0332394 (UMLS CUI)
6123003 (SNOMED CT 2010_0731)
InclusionCriterion_2
Item
completion of primary surgical therapy with R0 (no tumor residues) or R1 (microscopic residues) resection
boolean
C0920424 (UMLS CUI)
InclusionCriterion_3
Item
Karnofsky index > 70 %
boolean
C0206065 (UMLS CUI)
10054755 (MDR)
273546003 (SNOMED CT 2010_0731)
InclusionCriterion_4
Item
freedom from distant metastases at the time of initial radioiodine therapy
boolean
C0027627 (UMLS CUI)
C79.9 (ICD10CM)
10061289 (MDR)
128462008 (SNOMED CT 2010_0731)
C0475093 (UMLS CUI)
169342009 (SNOMED CT 2010_0731)
InclusionCriterion_5
Item
informed patient consent
boolean
C0021430 (UMLS CUI)
Item Group
Exclusion criteria
ExclusionCriterion_1
Item
secondary malignancy except basalioma
boolean
C0865024 (UMLS CUI)
C0007117 (UMLS CUI)
10004146 (MDR)
254701007 (SNOMED CT 2010_0731)
ExclusionCriterion_2
Item
pregnancy
boolean
C0549206 (UMLS CUI)
10036586 (MDR)
77386006 (SNOMED CT 2010_0731)
ExclusionCriterion_3
Item
serious general disease
boolean
C0012634 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)
ExclusionCriterion_4
Item
serious psychiatric disorder
boolean
C0004936 (UMLS CUI)
F01-F99 (ICD10CM)
290-319.99 (ICD9CM)
10061284 (MDR)
74732009 (SNOMED CT 2010_0731)
ExclusionCriterion_5
Item
inability to give informed consent
boolean
C0021430 (UMLS CUI)
ExclusionCriterion_6
Item
previous RTx
boolean
C1522449 (UMLS CUI)
10037794 (MDR)
108290001 (SNOMED CT 2010_0731)
ExclusionCriterion_7
Item
recurrence of previous thyroid cancer
boolean
C0278861 (UMLS CUI)
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Healthy Subject
Item
Healthy Subject
string
C1708335 (UMLS CUI)
Papillary thyroid carcinoma
Item
Papillary thyroid carcinoma
string
C0238463 (UMLS CUI)
10033701 (MDR)
255029007 (SNOMED CT 2010_0731)
Follicular thyroid carcinoma
Item
Follicular thyroid carcinoma
string
C0206682 (UMLS CUI)
10016935 (MDR)
255028004 (SNOMED CT 2010_0731)
pT4 Stage Finding
Item
pT4 Stage Finding
string
C0332394 (UMLS CUI)
6123003 (SNOMED CT 2010_0731)
cancer surgery
Item
cancer surgery
string
C0920424 (UMLS CUI)
Karnofsky Performance Status
Item
Karnofsky Performance Status
string
C0206065 (UMLS CUI)
10054755 (MDR)
273546003 (SNOMED CT 2010_0731)
Neoplasm Metastasis
Item
Neoplasm Metastasis
string
C0027627 (UMLS CUI)
C79.9 (ICD10CM)
10061289 (MDR)
128462008 (SNOMED CT 2010_0731)
Thyroid tumor/metastasis irradiation
Item
Thyroid tumor/metastasis irradiation
string
C0475093 (UMLS CUI)
169342009 (SNOMED CT 2010_0731)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Secondary malignancy, unspecified site
Item
Secondary malignancy, unspecified site
string
C0865024 (UMLS CUI)
Basal cell carcinoma
Item
Basal cell carcinoma
string
C0007117 (UMLS CUI)
10004146 (MDR)
254701007 (SNOMED CT 2010_0731)
Patient currently pregnant
Item
Patient currently pregnant
string
C0549206 (UMLS CUI)
10036586 (MDR)
77386006 (SNOMED CT 2010_0731)
Disease
Item
Disease
string
C0012634 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)
Mental disorders
Item
Mental disorders
string
C0004936 (UMLS CUI)
F01-F99 (ICD10CM)
290-319.99 (ICD9CM)
10061284 (MDR)
74732009 (SNOMED CT 2010_0731)
Therapeutic radiology procedure
Item
Therapeutic radiology procedure
string
C1522449 (UMLS CUI)
10037794 (MDR)
108290001 (SNOMED CT 2010_0731)
Recurrent Thyroid Gland Carcinoma
Item
Recurrent Thyroid Gland Carcinoma
string
C0278861 (UMLS CUI)
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