ID

4574

Beschrijving

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.

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Versies (1)
  1. 11-12-13 11-12-13 - Martin Dugas
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11 december 2013

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Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00144079 # Thyroid Carcinoma

Duits Engels

Eligibility

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Beschrijving

Inclusion criteria

18 Years to 69 Years
Beschrijving

Age

Datatype

boolean

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

Healthy Volunteers

Datatype

boolean

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

InclusionCriterion_1

Datatype

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
Beschrijving

InclusionCriterion_2

Datatype

boolean

Alias
UMLS CUI
C0920424
Karnofsky index > 70 %
Beschrijving

InclusionCriterion_3

Datatype

boolean

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

InclusionCriterion_4

Datatype

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
Beschrijving

InclusionCriterion_5

Datatype

boolean

Alias
UMLS CUI
C0021430
Exclusion criteria
Beschrijving

Exclusion criteria

secondary malignancy except basalioma
Beschrijving

ExclusionCriterion_1

Datatype

boolean

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

ExclusionCriterion_2

Datatype

boolean

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

ExclusionCriterion_3

Datatype

boolean

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

ExclusionCriterion_4

Datatype

boolean

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

ExclusionCriterion_5

Datatype

boolean

Alias
UMLS CUI
C0021430
previous RTx
Beschrijving

ExclusionCriterion_6

Datatype

boolean

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

ExclusionCriterion_7

Datatype

boolean

Alias
UMLS CUI
C0278861
Medical Concepts
Beschrijving

Medical Concepts

Age
Beschrijving

Age

Datatype

string

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

Healthy Subject

Datatype

string

Alias
UMLS CUI
C1708335
Papillary thyroid carcinoma
Beschrijving

Papillary thyroid carcinoma

Datatype

string

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

Follicular thyroid carcinoma

Datatype

string

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

pT4 Stage Finding

Datatype

string

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

cancer surgery

Datatype

string

Alias
UMLS CUI
C0920424
Karnofsky Performance Status
Beschrijving

Karnofsky Performance Status

Datatype

string

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

Neoplasm Metastasis

Datatype

string

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

Thyroid tumor/metastasis irradiation

Datatype

string

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

Informed Consent

Datatype

string

Alias
UMLS CUI
C0021430
Secondary malignancy, unspecified site
Beschrijving

Secondary malignancy, unspecified site

Datatype

string

Alias
UMLS CUI
C0865024
Basal cell carcinoma
Beschrijving

Basal cell carcinoma

Datatype

string

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

Patient currently pregnant

Datatype

string

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

Disease

Datatype

string

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

Mental disorders

Datatype

string

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

Therapeutic radiology procedure

Datatype

string

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

Recurrent Thyroid Gland Carcinoma

Datatype

string

Alias
UMLS CUI
C0278861
Terug naar het begin van de pagina

Similar models

Eligibility

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
Terug naar het begin van de pagina 

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