ID

38040

Beschreibung

Radiotherapy After Primary Chemotherapy for Breastcancer; ODM derived from: https://clinicaltrials.gov/show/NCT01279304

Link

https://clinicaltrials.gov/show/NCT01279304

Stichworte

Versionen (1)
  1. 11.09.19 11.09.19 -
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See clinicaltrials.gov

Hochgeladen am

11. September 2019

DOI

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Eligibility Breast Cancer NCT01279304

Englisch

Eligibility Breast Cancer NCT01279304

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
ct1-2 invasive breast cancer, without or with one or more pathologically proven tumour positive axillary lymph nodes (either by sentinel node biopsy, ultrasound/palpation guided biopsy or fine needle aspiration)
Beschreibung

Breast Carcinoma TNM Breast tumor staging | Positive Axillary Lymph Node Absent | Positive Axillary Lymph Node Quantity Sentinel Lymph Node Biopsy | Positive Axillary Lymph Node Quantity Ultrasound guided biopsy | Positive Axillary Lymph Node Quantity Core needle biopsy of breast using palpation guidance | Positive Axillary Lymph Node Quantity Fine needle aspiration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0677929
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0677929
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0796693
UMLS CUI [4,1]
C0677929
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0456900
UMLS CUI [5,1]
C0677929
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C2919889
UMLS CUI [6,1]
C0677929
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C1510483
at least 3 cycles of primary systemic treatment have been given (irrespective of the regimen)
Beschreibung

Systemic therapy Course Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1265611
no standard axillary lymph node dissection is performed prior to chemotherapy
Beschreibung

Excision of axillary lymph nodes Absent | Status pre- Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0193867
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0392920
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
ct3-t4 invasive breast cancer prior to any treatment
Beschreibung

Invasive carcinoma of breast TNM Breast tumor staging | Status pre- Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0087111
patients with > 3 suspicious axillary nodes on imaging
Beschreibung

Axillary lymph nodes Suspicious Quantity Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C0750493
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0011923
cn2-3 prior to any treatment
Beschreibung

TNM Breast tumor staging | Status pre- Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0474926
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0087111
more than focally irradical surgery and breast conserving therapy
Beschreibung

Operative Surgical Procedure Focal | Breast-Conserving Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205234
UMLS CUI [2]
C0917927
to investigate whether a patient is eligible for the rapchem study, a meticulous examination of the axilla is necessary. therefore each patient should undergo an ultrasound of the axilla and if possible an ultrasound guided needle biopsy unb (fna or core). the us/unb can be performed instantly or as second look in case of enlarged nodes on mri. the criteria for performing an unb are:
Beschreibung

Eligibility Clinical Trial Specified | Axilla Ultrasonography | Fine needle aspiration biopsy of axilla using ultrasound guidance | Core needle biopsy of axilla using ultrasound guidance | Lymphadenopathy MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C0004454
UMLS CUI [2,2]
C0041618
UMLS CUI [3]
C2316139
UMLS CUI [4]
C2316399
UMLS CUI [5,1]
C0497156
UMLS CUI [5,2]
C0024485
cortex >2.3 mm not measured at the poles of the node; or
Beschreibung

Cortex of lymph node Length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0933402
UMLS CUI [1,2]
C1444754
disappearance of the fatty hilum; or
Beschreibung

Absence Hilum Fatty

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0229703
UMLS CUI [1,3]
C0001527
asymmetric bulging of the cortex of a lymph node;
Beschreibung

Cortex of lymph node Bulging Asymmetric

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0933402
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C0332514
if a pet-ct is performed the worst outcome of the two studies is accepted as the real clinical stage of the axilla (i.e. 1 pa proven positive lymph node on ultrasound and 3 on pet-ct; means 3 positive lymph nodes)
Beschreibung

Axilla TNM clinical staging PET/CT scan | Axilla TNM clinical staging Ultrasonography | Axillary lymph nodes Positive Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004454
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C1699633
UMLS CUI [2,1]
C0004454
UMLS CUI [2,2]
C3258246
UMLS CUI [2,3]
C0041618
UMLS CUI [3,1]
C0729594
UMLS CUI [3,2]
C1514241
UMLS CUI [3,3]
C1265611
the n status of the axilla prior to chemotherapy is based upon:
Beschreibung

Axilla TNM clinical staging | Status pre- Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004454
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0392920
positive pet-ct of more than one but less than 4 axillary nodes; since the specificity of pet positive nodes in a proven breast cancer patient is very high, pathology confirmation is not absolutely required
Beschreibung

Axillary lymph nodes Positive Quantity PET/CT scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1699633
positive us of axillary nodes; at least one should be pathology proven tumour positive
Beschreibung

Axillary lymph nodes Positive Ultrasonography | Axillary lymph nodes Positive Quantity Pathology

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0041618
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0919386
the worst outcome of 1 and 2 represents the most reliable clinical axillary staging.
Beschreibung

Axillary lymph nodes TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C3258246
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Ähnliche Modelle

Eligibility Breast Cancer NCT01279304

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging | Positive Axillary Lymph Node Absent | Positive Axillary Lymph Node Quantity Sentinel Lymph Node Biopsy | Positive Axillary Lymph Node Quantity Ultrasound guided biopsy | Positive Axillary Lymph Node Quantity Core needle biopsy of breast using palpation guidance | Positive Axillary Lymph Node Quantity Fine needle aspiration
Item
ct1-2 invasive breast cancer, without or with one or more pathologically proven tumour positive axillary lymph nodes (either by sentinel node biopsy, ultrasound/palpation guided biopsy or fine needle aspiration)
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0677929 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0677929 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0796693 (UMLS CUI [3,3])
C0677929 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0456900 (UMLS CUI [4,3])
C0677929 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C2919889 (UMLS CUI [5,3])
C0677929 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C1510483 (UMLS CUI [6,3])
Systemic therapy Course Quantity
Item
at least 3 cycles of primary systemic treatment have been given (irrespective of the regimen)
boolean
C1515119 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Excision of axillary lymph nodes Absent | Status pre- Chemotherapy
Item
no standard axillary lymph node dissection is performed prior to chemotherapy
boolean
C0193867 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Invasive carcinoma of breast TNM Breast tumor staging | Status pre- Therapeutic procedure
Item
ct3-t4 invasive breast cancer prior to any treatment
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Axillary lymph nodes Suspicious Quantity Imaging
Item
patients with > 3 suspicious axillary nodes on imaging
boolean
C0729594 (UMLS CUI [1,1])
C0750493 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0011923 (UMLS CUI [1,4])
TNM Breast tumor staging | Status pre- Therapeutic procedure
Item
cn2-3 prior to any treatment
boolean
C0474926 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Operative Surgical Procedure Focal | Breast-Conserving Surgery
Item
more than focally irradical surgery and breast conserving therapy
boolean
C0543467 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0917927 (UMLS CUI [2])
Eligibility Clinical Trial Specified | Axilla Ultrasonography | Fine needle aspiration biopsy of axilla using ultrasound guidance | Core needle biopsy of axilla using ultrasound guidance | Lymphadenopathy MRI
Item
to investigate whether a patient is eligible for the rapchem study, a meticulous examination of the axilla is necessary. therefore each patient should undergo an ultrasound of the axilla and if possible an ultrasound guided needle biopsy unb (fna or core). the us/unb can be performed instantly or as second look in case of enlarged nodes on mri. the criteria for performing an unb are:
boolean
C1548635 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0004454 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
C2316139 (UMLS CUI [3])
C2316399 (UMLS CUI [4])
C0497156 (UMLS CUI [5,1])
C0024485 (UMLS CUI [5,2])
Cortex of lymph node Length
Item
cortex >2.3 mm not measured at the poles of the node; or
boolean
C0933402 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Absence Hilum Fatty
Item
disappearance of the fatty hilum; or
boolean
C0332197 (UMLS CUI [1,1])
C0229703 (UMLS CUI [1,2])
C0001527 (UMLS CUI [1,3])
Cortex of lymph node Bulging Asymmetric
Item
asymmetric bulging of the cortex of a lymph node;
boolean
C0933402 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0332514 (UMLS CUI [1,3])
Axilla TNM clinical staging PET/CT scan | Axilla TNM clinical staging Ultrasonography | Axillary lymph nodes Positive Quantity
Item
if a pet-ct is performed the worst outcome of the two studies is accepted as the real clinical stage of the axilla (i.e. 1 pa proven positive lymph node on ultrasound and 3 on pet-ct; means 3 positive lymph nodes)
boolean
C0004454 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1699633 (UMLS CUI [1,3])
C0004454 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
C0729594 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Axilla TNM clinical staging | Status pre- Chemotherapy
Item
the n status of the axilla prior to chemotherapy is based upon:
boolean
C0004454 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
Axillary lymph nodes Positive Quantity PET/CT scan
Item
positive pet-ct of more than one but less than 4 axillary nodes; since the specificity of pet positive nodes in a proven breast cancer patient is very high, pathology confirmation is not absolutely required
boolean
C0729594 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1699633 (UMLS CUI [1,4])
Axillary lymph nodes Positive Ultrasonography | Axillary lymph nodes Positive Quantity Pathology
Item
positive us of axillary nodes; at least one should be pathology proven tumour positive
boolean
C0729594 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
C0729594 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0919386 (UMLS CUI [2,4])
Axillary lymph nodes TNM clinical staging
Item
the worst outcome of 1 and 2 represents the most reliable clinical axillary staging.
boolean
C0729594 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
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