ID

43629

Beschreibung

Study of Tumor and Blood Samples From Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00897728

Link

https://clinicaltrials.gov/show/NCT00897728

Stichworte

Versionen (2)
  1. 25.10.17 25.10.17 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00897728

Englisch

Eligibility Breast Cancer NCT00897728

1 Formulare  
Criteria
Beschreibung

Criteria

diagnosis of infiltrating unilateral breast cancer
Beschreibung

Invasive carcinoma of breast Unilateral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205092
no in situ disease (ductal or lobular)
Beschreibung

Exclusion Criteria | Noninfiltrating Intraductal Carcinoma | Non-infiltrating lobular carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0007124
UMLS CUI [3]
C0334381
no invasive bilateral synchronous disease
Beschreibung

Exclusion | Invasive Carcinoma Synchronous Bilateral

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C1334274
UMLS CUI [2,2]
C0439580
UMLS CUI [2,3]
C0238767
breast cancer at high risk, defined by at least 2 of the following factors:
Beschreibung

Breast Carcinoma High risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0332167
hormone receptor negative (hr-)
Beschreibung

Hormone Receptor Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1513916
axillary node positive
Beschreibung

Positive Axillary Lymph Node

Datentyp

boolean

Alias
UMLS CUI [1]
C0677929
histopathologic grade iii
Beschreibung

TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0474926
high mitotic index (as defined by the curie institute as > 20 mitoses per 10 high-power fields [hpf])
Beschreibung

Index Mitotic High

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0918012
UMLS CUI [1,2]
C1513354
UMLS CUI [1,3]
C0205250
tumor size ≥ 2 cm
Beschreibung

Tumor size

Datentyp

boolean

Alias
UMLS CUI [1]
C0475440
her2-positive (3 + ihc or fish/ichs positive)
Beschreibung

HER2/Neu Positive Immunohistochemistry Positive | HER2/Neu Positive FISH Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348909
UMLS CUI [1,2]
C0021044
UMLS CUI [1,3]
C1514241
UMLS CUI [2,1]
C2348909
UMLS CUI [2,2]
C0162789
UMLS CUI [2,3]
C1514241
triple-negative tumors (hr- and her2-negative)
Beschreibung

Triple-Negative Breast Cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C2348819
initial thoracic-abdomino-pelvic and bone scans must be negative
Beschreibung

Thorax scan Initial Negative | Abdomen scan Initial Negative | CT of Pelvis Initial Negative | Bone scan Initial Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3888834
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0860675
UMLS CUI [2,2]
C0205265
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C0412628
UMLS CUI [3,2]
C0205265
UMLS CUI [3,3]
C1513916
UMLS CUI [4,1]
C0203668
UMLS CUI [4,2]
C0205265
UMLS CUI [4,3]
C1513916
underwent initial surgery
Beschreibung

Operative Surgical Procedures Initial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205265
patient characteristics:
Beschreibung

Client Characteristics

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
menopausal status not specified
Beschreibung

Menopausal Status Unspecified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
serum calcium normal (15.3 mg/dl) or normalized within 8 weeks after surgery
Beschreibung

Serum calcium normal | Serum Calcium Normalized Post Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0858094
UMLS CUI [2,1]
C0036785
UMLS CUI [2,2]
C1882115
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C0543467
no other invasive cancer within the past 5 years
Beschreibung

Exclusion | Invasive cancer Other

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0677898
UMLS CUI [2,2]
C0205394
not pregnant or nursing
Beschreibung

Exclusion Criteria | Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
no psychological, familial, social, or geographical reasons that make monitoring impossible
Beschreibung

Exclusion | Factor Monitoring Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C1283169
UMLS CUI [2,3]
C1272705
prior concurrent therapy:
Beschreibung

Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beschreibung

ID.21

Datentyp

boolean

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Ähnliche Modelle

Eligibility Breast Cancer NCT00897728

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Invasive carcinoma of breast Unilateral
Item
diagnosis of infiltrating unilateral breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
Exclusion Criteria | Noninfiltrating Intraductal Carcinoma | Non-infiltrating lobular carcinoma
Item
no in situ disease (ductal or lobular)
boolean
C0680251 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
C0334381 (UMLS CUI [3])
Exclusion | Invasive Carcinoma Synchronous Bilateral
Item
no invasive bilateral synchronous disease
boolean
C2828389 (UMLS CUI [1])
C1334274 (UMLS CUI [2,1])
C0439580 (UMLS CUI [2,2])
C0238767 (UMLS CUI [2,3])
Breast Carcinoma High risk
Item
breast cancer at high risk, defined by at least 2 of the following factors:
boolean
C0678222 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
Hormone Receptor Negative
Item
hormone receptor negative (hr-)
boolean
C0019929 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Positive Axillary Lymph Node
Item
axillary node positive
boolean
C0677929 (UMLS CUI [1])
TNM Breast tumor staging
Item
histopathologic grade iii
boolean
C0474926 (UMLS CUI [1])
Index Mitotic High
Item
high mitotic index (as defined by the curie institute as > 20 mitoses per 10 high-power fields [hpf])
boolean
C0918012 (UMLS CUI [1,1])
C1513354 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Tumor size
Item
tumor size ≥ 2 cm
boolean
C0475440 (UMLS CUI [1])
HER2/Neu Positive Immunohistochemistry Positive | HER2/Neu Positive FISH Positive
Item
her2-positive (3 + ihc or fish/ichs positive)
boolean
C2348909 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C2348909 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Triple-Negative Breast Cancer
Item
triple-negative tumors (hr- and her2-negative)
boolean
C2348819 (UMLS CUI [1])
Thorax scan Initial Negative | Abdomen scan Initial Negative | CT of Pelvis Initial Negative | Bone scan Initial Negative
Item
initial thoracic-abdomino-pelvic and bone scans must be negative
boolean
C3888834 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0860675 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0412628 (UMLS CUI [3,1])
C0205265 (UMLS CUI [3,2])
C1513916 (UMLS CUI [3,3])
C0203668 (UMLS CUI [4,1])
C0205265 (UMLS CUI [4,2])
C1513916 (UMLS CUI [4,3])
Operative Surgical Procedures Initial
Item
underwent initial surgery
boolean
C0543467 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C3829127 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
Serum calcium normal | Serum Calcium Normalized Post Operative Surgical Procedures
Item
serum calcium normal (15.3 mg/dl) or normalized within 8 weeks after surgery
boolean
C0858094 (UMLS CUI [1])
C0036785 (UMLS CUI [2,1])
C1882115 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0543467 (UMLS CUI [2,4])
Exclusion | Invasive cancer Other
Item
no other invasive cancer within the past 5 years
boolean
C2828389 (UMLS CUI [1])
C0677898 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Exclusion Criteria | Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0680251 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Exclusion | Factor Monitoring Unsuccessful
Item
no psychological, familial, social, or geographical reasons that make monitoring impossible
boolean
C2828389 (UMLS CUI [1])
C1521761 (UMLS CUI [2,1])
C1283169 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.21
Item
see disease characteristics
boolean
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