ID

4574

Beschreibung

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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  1. 11.12.13 11.12.13 - Martin Dugas
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11. Dezember 2013

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Eligibility NCT00144079 # Thyroid Carcinoma

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Beschreibung

Inclusion criteria

18 Years to 69 Years
Beschreibung

Age

Datentyp

boolean

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

Healthy Volunteers

Datentyp

boolean

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

InclusionCriterion_1

Datentyp

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
Beschreibung

InclusionCriterion_2

Datentyp

boolean

Alias
UMLS CUI
C0920424
Karnofsky index > 70 %
Beschreibung

InclusionCriterion_3

Datentyp

boolean

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

InclusionCriterion_4

Datentyp

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
Beschreibung

InclusionCriterion_5

Datentyp

boolean

Alias
UMLS CUI
C0021430
Exclusion criteria
Beschreibung

Exclusion criteria

secondary malignancy except basalioma
Beschreibung

ExclusionCriterion_1

Datentyp

boolean

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

ExclusionCriterion_2

Datentyp

boolean

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

ExclusionCriterion_3

Datentyp

boolean

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

ExclusionCriterion_4

Datentyp

boolean

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

ExclusionCriterion_5

Datentyp

boolean

Alias
UMLS CUI
C0021430
previous RTx
Beschreibung

ExclusionCriterion_6

Datentyp

boolean

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

ExclusionCriterion_7

Datentyp

boolean

Alias
UMLS CUI
C0278861
Medical Concepts
Beschreibung

Medical Concepts

Age
Beschreibung

Age

Datentyp

string

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

Healthy Subject

Datentyp

string

Alias
UMLS CUI
C1708335
Papillary thyroid carcinoma
Beschreibung

Papillary thyroid carcinoma

Datentyp

string

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

Follicular thyroid carcinoma

Datentyp

string

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

pT4 Stage Finding

Datentyp

string

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

cancer surgery

Datentyp

string

Alias
UMLS CUI
C0920424
Karnofsky Performance Status
Beschreibung

Karnofsky Performance Status

Datentyp

string

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

Neoplasm Metastasis

Datentyp

string

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

Thyroid tumor/metastasis irradiation

Datentyp

string

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

Informed Consent

Datentyp

string

Alias
UMLS CUI
C0021430
Secondary malignancy, unspecified site
Beschreibung

Secondary malignancy, unspecified site

Datentyp

string

Alias
UMLS CUI
C0865024
Basal cell carcinoma
Beschreibung

Basal cell carcinoma

Datentyp

string

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

Patient currently pregnant

Datentyp

string

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

Disease

Datentyp

string

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

Mental disorders

Datentyp

string

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

Therapeutic radiology procedure

Datentyp

string

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

Recurrent Thyroid Gland Carcinoma

Datentyp

string

Alias
UMLS CUI
C0278861
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
Zum Seitenanfang zurückkehren 

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