ID

26629

Beschreibung

Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00743314

Link

https://clinicaltrials.gov/show/NCT00743314

Stichworte

Versionen (2)
  1. 19.10.17 19.10.17 -
  2. 22.10.17 22.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

22. Oktober 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00743314

Englisch

Eligibility Breast Cancer NCT00743314

1 Formulare  
Criteria
Beschreibung

Criteria

biopsy-proven primary invasive breast cancer, meeting one of the following criteria:
Beschreibung

Invasive carcinoma of breast Primary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205225
stage i or ii disease with negative sentinel or axillary node dissections
Beschreibung

TNM Breast tumor staging | Sentinel Lymph Node Negative Dissection | Negative Axillary Lymph Node Dissection

Datentyp

boolean

Alias
UMLS CUI [1]
C0474926
UMLS CUI [2,1]
C1522495
UMLS CUI [2,2]
C1513916
UMLS CUI [2,3]
C0012737
UMLS CUI [3,1]
C0279781
UMLS CUI [3,2]
C0012737
stage ii disease with micrometastases (defined as < 2.0 mm focus) in 1-2 lymph nodes and/or a single positive axillary node ≤ 1 cm with no extracapsular extension
Beschreibung

TNM Breast tumor staging | Micrometastasis Lymph nodes Quantity | Focus Size | Positive Axillary Lymph Node Single Size | Extension Extracapsular Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0474926
UMLS CUI [2,1]
C1513276
UMLS CUI [2,2]
C0024204
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0205234
UMLS CUI [3,2]
C0456389
UMLS CUI [4,1]
C0677929
UMLS CUI [4,2]
C0205171
UMLS CUI [4,3]
C0456389
UMLS CUI [5,1]
C0231448
UMLS CUI [5,2]
C1517049
UMLS CUI [5,3]
C0332197
completed all surgical intervention (e.g., lumpectomy, mastectomy)
Beschreibung

Operative Surgical Procedures Completed | Lumpectomy | Mastectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0024885
UMLS CUI [3]
C0024881
planning adjuvant whole breast irradiation including the low axilla
Beschreibung

Whole Breast Irradiation Adjuvant Planned | Therapeutic radiology procedure Axilla low Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3897169
UMLS CUI [1,2]
C1522673
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0004454
UMLS CUI [2,3]
C0205251
UMLS CUI [2,4]
C1301732
no bilateral or recurrent breast cancer
Beschreibung

Bilateral breast cancer Absent | Breast cancer recurrent Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0281267
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C0332197
patient characteristics:
Beschreibung

Client Characteristics

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
not pregnancy or nursing
Beschreibung

Pregnancy Absent | Breast Feeding Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Beschreibung

Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0427780
able to complete questionnaire(s) alone or with assistance
Beschreibung

Questionnaire Completion | Questionnaire Completion Assisted

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C1269765
no active infection
Beschreibung

Communicable Disease Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C2828389
no history of invasive cancer within the past 5 years, except basal cell or squamous cell skin cancers
Beschreibung

Invasive cancer Excluded | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
prior concurrent therapy:
Beschreibung

Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beschreibung

ID.15

Datentyp

boolean

no prior surgery or radiation to the ipsilateral breast or axilla
Beschreibung

Operation on breast Ipsilateral Excluded | Operative Surgical Procedures Axilla Ipsilateral Excluded | Therapeutic radiology procedure Breast Ipsilateral Excluded | Radiotherapy to axilla Ipsilateral Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0441989
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0004454
UMLS CUI [2,3]
C0441989
UMLS CUI [2,4]
C2828389
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0006141
UMLS CUI [3,3]
C0441989
UMLS CUI [3,4]
C2828389
UMLS CUI [4,1]
C1997064
UMLS CUI [4,2]
C0441989
UMLS CUI [4,3]
C2828389
no concurrent neoadjuvant chemotherapy or radiotherapy
Beschreibung

Chemotherapy Neoadjuvant Excluded | Therapeutic radiology procedure Neoadjuvant Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C2828389
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Ähnliche Modelle

Eligibility Breast Cancer NCT00743314

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Invasive carcinoma of breast Primary
Item
biopsy-proven primary invasive breast cancer, meeting one of the following criteria:
boolean
C0853879 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
TNM Breast tumor staging | Sentinel Lymph Node Negative Dissection | Negative Axillary Lymph Node Dissection
Item
stage i or ii disease with negative sentinel or axillary node dissections
boolean
C0474926 (UMLS CUI [1])
C1522495 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0012737 (UMLS CUI [2,3])
C0279781 (UMLS CUI [3,1])
C0012737 (UMLS CUI [3,2])
TNM Breast tumor staging | Micrometastasis Lymph nodes Quantity | Focus Size | Positive Axillary Lymph Node Single Size | Extension Extracapsular Absent
Item
stage ii disease with micrometastases (defined as < 2.0 mm focus) in 1-2 lymph nodes and/or a single positive axillary node ≤ 1 cm with no extracapsular extension
boolean
C0474926 (UMLS CUI [1])
C1513276 (UMLS CUI [2,1])
C0024204 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0205234 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0677929 (UMLS CUI [4,1])
C0205171 (UMLS CUI [4,2])
C0456389 (UMLS CUI [4,3])
C0231448 (UMLS CUI [5,1])
C1517049 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Operative Surgical Procedures Completed | Lumpectomy | Mastectomy
Item
completed all surgical intervention (e.g., lumpectomy, mastectomy)
boolean
C0543467 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0024885 (UMLS CUI [2])
C0024881 (UMLS CUI [3])
Whole Breast Irradiation Adjuvant Planned | Therapeutic radiology procedure Axilla low Planned
Item
planning adjuvant whole breast irradiation including the low axilla
boolean
C3897169 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
C0205251 (UMLS CUI [2,3])
C1301732 (UMLS CUI [2,4])
Bilateral breast cancer Absent | Breast cancer recurrent Absent
Item
no bilateral or recurrent breast cancer
boolean
C0281267 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnancy or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Questionnaire Completion | Questionnaire Completion Assisted
Item
able to complete questionnaire(s) alone or with assistance
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1269765 (UMLS CUI [2,3])
Communicable Disease Excluded
Item
no active infection
boolean
C0009450 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Invasive cancer Excluded | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
no history of invasive cancer within the past 5 years, except basal cell or squamous cell skin cancers
boolean
C0677898 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.15
Item
see disease characteristics
boolean
Operation on breast Ipsilateral Excluded | Operative Surgical Procedures Axilla Ipsilateral Excluded | Therapeutic radiology procedure Breast Ipsilateral Excluded | Radiotherapy to axilla Ipsilateral Excluded
Item
no prior surgery or radiation to the ipsilateral breast or axilla
boolean
C3714726 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
C0441989 (UMLS CUI [2,3])
C2828389 (UMLS CUI [2,4])
C1522449 (UMLS CUI [3,1])
C0006141 (UMLS CUI [3,2])
C0441989 (UMLS CUI [3,3])
C2828389 (UMLS CUI [3,4])
C1997064 (UMLS CUI [4,1])
C0441989 (UMLS CUI [4,2])
C2828389 (UMLS CUI [4,3])
Chemotherapy Neoadjuvant Excluded | Therapeutic radiology procedure Neoadjuvant Excluded
Item
no concurrent neoadjuvant chemotherapy or radiotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
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