ID

38230

Beschreibung

Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence; ODM derived from: https://clinicaltrials.gov/show/NCT01479244

Link

https://clinicaltrials.gov/show/NCT01479244

Stichworte

Versionen (1)
  1. 30.09.19 30.09.19 -
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See clinicaltrials.gov

Hochgeladen am

30. September 2019

DOI

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Eligibility Breast Cancer With Low to Intermediate HER2 Expression NCT01479244

Englisch

Eligibility Breast Cancer With Low to Intermediate HER2 Expression NCT01479244

1 Formulare  
Criteria
Beschreibung

Criteria

pathological diagnosis of invasive adenocarcinoma of the breast
Beschreibung

Breast adenocarcinoma Invasive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
breast cancer completely excised, or patient receiving neoadjuvant therapy prior to surgery
Beschreibung

Complete excision Breast Carcinoma | Neoadjuvant Therapy prior to Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015250
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0543467
one of these 2 surgical treatments and axillary staging with sentinel lymph node dissection or axillary dissection level i/ii:
Beschreibung

Operative Surgical Procedures Quantity | Axillary lymph nodes Staging | Excision of sentinel lymph node | Excision of axillary lymph nodes Level

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C0332305
UMLS CUI [3]
C2733271
UMLS CUI [4,1]
C0193867
UMLS CUI [4,2]
C0441889
1. total mastectomy-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level i/ii
Beschreibung

Simple mastectomy | Sentinel Lymph Node Positive | Excision of axillary lymph nodes Level Completion

Datentyp

boolean

Alias
UMLS CUI [1]
C0024886
UMLS CUI [2,1]
C1522495
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0193867
UMLS CUI [3,2]
C0441889
UMLS CUI [3,3]
C0205197
2. bcs (lumpectomy)-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level i/ii unless they had clinically node negative t1-t2 tumors and fewer than 3 involved lymph nodes
Beschreibung

Breast-Conserving Surgery | Segmental Mastectomy | Sentinel Lymph Node Positive | Excision of axillary lymph nodes Level Completion | Exception Neoplasms Negative Lymph Node TNM Breast tumor staging | Exception Lymph nodes Involved Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0917927
UMLS CUI [2]
C0024885
UMLS CUI [3,1]
C1522495
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C0193867
UMLS CUI [4,2]
C0441889
UMLS CUI [4,3]
C0205197
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0027651
UMLS CUI [5,3]
C0678034
UMLS CUI [5,4]
C0474926
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0024204
UMLS CUI [6,3]
C1314939
UMLS CUI [6,4]
C1265611
node-positive disease
Beschreibung

Disease Lymph node positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0746319
primary tumor stage t1-3 at initial diagnosis
Beschreibung

Primary tumor TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0474926
her2 negative (her2 1+ by ihc or her2 2+ by ihc/fish)
Beschreibung

HER2 Negative Immunohistochemistry | HER2 Negative FISH

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348908
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C2348908
UMLS CUI [2,2]
C0162789
hla-a2 or hla-a3 haplotype
Beschreibung

HLA-A2 Haplotype | HLA-A3 Haplotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019733
UMLS CUI [1,2]
C0018591
UMLS CUI [2,1]
C0019735
UMLS CUI [2,2]
C0018591
completed nccn approved neo-adjuvant/adjuvant chemotherapy or both
Beschreibung

Neoadjuvant Chemotherapy Completed | Adjuvant Chemotherapy Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0205197
completed radiation therapy
Beschreibung

Therapeutic radiology procedure Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
no evidence of disease
Beschreibung

Disease Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332197
able and willing (or have legal representative) to understand the study and provide consent
Beschreibung

Comprehension Study Protocol | Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030701
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
bilateral breast malignancy or suspicious mass in opposite breast
Beschreibung

Bilateral breast cancer | Mass Suspicious | Breast Opposite

Datentyp

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2,1]
C0577559
UMLS CUI [2,2]
C0750493
UMLS CUI [3,1]
C0006141
UMLS CUI [3,2]
C1521805
inflammatory breast malignancy
Beschreibung

Inflammatory Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0278601
history of prior breast cancer, ductal carcinoma in situ
Beschreibung

Breast Carcinoma Previous | DCIS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0007124
prior trastuzumab therapy
Beschreibung

trastuzumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0728747
new york heart association stage 3 or 4 cardiac disease
Beschreibung

Heart Disease New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
sensory/motor neuropathy ≥ grade 2
Beschreibung

Sensory neuropathy CTCAE Grades | Motor neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0235025
UMLS CUI [2,2]
C1516728
autoimmune diseases or immune deficiency disease
Beschreibung

Autoimmune Diseases | Immunodeficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021051
subjects on chronic steroid therapy, other immunosuppressive therapy
Beschreibung

Steroid therapy chronic | Therapeutic immunosuppression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0021079
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Ähnliche Modelle

Eligibility Breast Cancer With Low to Intermediate HER2 Expression NCT01479244

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Breast adenocarcinoma Invasive
Item
pathological diagnosis of invasive adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
Complete excision Breast Carcinoma | Neoadjuvant Therapy prior to Operative Surgical Procedures
Item
breast cancer completely excised, or patient receiving neoadjuvant therapy prior to surgery
boolean
C0015250 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Operative Surgical Procedures Quantity | Axillary lymph nodes Staging | Excision of sentinel lymph node | Excision of axillary lymph nodes Level
Item
one of these 2 surgical treatments and axillary staging with sentinel lymph node dissection or axillary dissection level i/ii:
boolean
C0543467 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0729594 (UMLS CUI [2,1])
C0332305 (UMLS CUI [2,2])
C2733271 (UMLS CUI [3])
C0193867 (UMLS CUI [4,1])
C0441889 (UMLS CUI [4,2])
Simple mastectomy | Sentinel Lymph Node Positive | Excision of axillary lymph nodes Level Completion
Item
1. total mastectomy-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level i/ii
boolean
C0024886 (UMLS CUI [1])
C1522495 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0193867 (UMLS CUI [3,1])
C0441889 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Breast-Conserving Surgery | Segmental Mastectomy | Sentinel Lymph Node Positive | Excision of axillary lymph nodes Level Completion | Exception Neoplasms Negative Lymph Node TNM Breast tumor staging | Exception Lymph nodes Involved Quantity
Item
2. bcs (lumpectomy)-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level i/ii unless they had clinically node negative t1-t2 tumors and fewer than 3 involved lymph nodes
boolean
C0917927 (UMLS CUI [1])
C0024885 (UMLS CUI [2])
C1522495 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0193867 (UMLS CUI [4,1])
C0441889 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0027651 (UMLS CUI [5,2])
C0678034 (UMLS CUI [5,3])
C0474926 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0024204 (UMLS CUI [6,2])
C1314939 (UMLS CUI [6,3])
C1265611 (UMLS CUI [6,4])
Disease Lymph node positive
Item
node-positive disease
boolean
C0012634 (UMLS CUI [1,1])
C0746319 (UMLS CUI [1,2])
Primary tumor TNM Breast tumor staging
Item
primary tumor stage t1-3 at initial diagnosis
boolean
C0677930 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
HER2 Negative Immunohistochemistry | HER2 Negative FISH
Item
her2 negative (her2 1+ by ihc or her2 2+ by ihc/fish)
boolean
C2348908 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C2348908 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
HLA-A2 Haplotype | HLA-A3 Haplotype
Item
hla-a2 or hla-a3 haplotype
boolean
C0019733 (UMLS CUI [1,1])
C0018591 (UMLS CUI [1,2])
C0019735 (UMLS CUI [2,1])
C0018591 (UMLS CUI [2,2])
Neoadjuvant Chemotherapy Completed | Adjuvant Chemotherapy Completed
Item
completed nccn approved neo-adjuvant/adjuvant chemotherapy or both
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Therapeutic radiology procedure Completed
Item
completed radiation therapy
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Disease Absent
Item
no evidence of disease
boolean
C0012634 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Comprehension Study Protocol | Informed Consent | Informed Consent Patient Representative
Item
able and willing (or have legal representative) to understand the study and provide consent
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C0030701 (UMLS CUI [3,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Bilateral breast cancer | Mass Suspicious | Breast Opposite
Item
bilateral breast malignancy or suspicious mass in opposite breast
boolean
C0281267 (UMLS CUI [1])
C0577559 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0006141 (UMLS CUI [3,1])
C1521805 (UMLS CUI [3,2])
Inflammatory Breast Carcinoma
Item
inflammatory breast malignancy
boolean
C0278601 (UMLS CUI [1])
Breast Carcinoma Previous | DCIS
Item
history of prior breast cancer, ductal carcinoma in situ
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
trastuzumab
Item
prior trastuzumab therapy
boolean
C0728747 (UMLS CUI [1])
Heart Disease New York Heart Association Classification
Item
new york heart association stage 3 or 4 cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Sensory neuropathy CTCAE Grades | Motor neuropathy CTCAE Grades
Item
sensory/motor neuropathy ≥ grade 2
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0235025 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Autoimmune Diseases | Immunodeficiency
Item
autoimmune diseases or immune deficiency disease
boolean
C0004364 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Steroid therapy chronic | Therapeutic immunosuppression
Item
subjects on chronic steroid therapy, other immunosuppressive therapy
boolean
C0149783 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2])
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