ID

38230

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01479244

Nyckelord

Versioner (1)
  1. 2019-09-30 2019-09-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 september 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Breast Cancer With Low to Intermediate HER2 Expression NCT01479244

Engelsk

Eligibility Breast Cancer With Low to Intermediate HER2 Expression NCT01479244

1 Formulär  
Criteria
Beskrivning

Criteria

pathological diagnosis of invasive adenocarcinoma of the breast
Beskrivning

Breast adenocarcinoma Invasive

Datatyp

boolean

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

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

Datatyp

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:
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Disease Lymph node positive

Datatyp

boolean

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

Primary tumor TNM Breast tumor staging

Datatyp

boolean

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

HER2 Negative Immunohistochemistry | HER2 Negative FISH

Datatyp

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
Beskrivning

HLA-A2 Haplotype | HLA-A3 Haplotype

Datatyp

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
Beskrivning

Neoadjuvant Chemotherapy Completed | Adjuvant Chemotherapy Completed

Datatyp

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
Beskrivning

Therapeutic radiology procedure Completed

Datatyp

boolean

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

Disease Absent

Datatyp

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
Beskrivning

Comprehension Study Protocol | Informed Consent | Informed Consent Patient Representative

Datatyp

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:
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

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

Bilateral breast cancer | Mass Suspicious | Breast Opposite

Datatyp

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
Beskrivning

Inflammatory Breast Carcinoma

Datatyp

boolean

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

Breast Carcinoma Previous | DCIS

Datatyp

boolean

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

trastuzumab

Datatyp

boolean

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

Heart Disease New York Heart Association Classification

Datatyp

boolean

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

Sensory neuropathy CTCAE Grades | Motor neuropathy CTCAE Grades

Datatyp

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
Beskrivning

Autoimmune Diseases | Immunodeficiency

Datatyp

boolean

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

Steroid therapy chronic | Therapeutic immunosuppression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0021079
Tillbaka till toppen

Similar models

Eligibility Breast Cancer With Low to Intermediate HER2 Expression NCT01479244

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial