ID

16430

Beschreibung

Studying Cells Collected Through Ductal Lavage in Women Undergoing Surgery for Ductal Carcinoma In Situ or Other Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00896857

Link

https://clinicaltrials.gov/show/NCT00896857

Stichworte

Versionen (1)
  1. 16.07.16 16.07.16 -
Hochgeladen am

16. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00896857

Englisch

Eligibility Breast Cancer NCT00896857

1 Formulare  
Criteria
Beschreibung

Criteria

agrees to undergo breast surgical procedure and meets one of the following criteria:
Beschreibung

agrees to undergo breast surgical procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2972960
UMLS CUI [1,2]
C3714726
scheduled to undergo breast biopsy based on suspicious mammographic or clinical breast examination findings
Beschreibung

scheduled to undergo breast biopsy based on suspicious mammographic or clinical breast examination findings

Datentyp

boolean

Alias
UMLS CUI [1]
C0405352
UMLS CUI [2]
C1742735
UMLS CUI [3]
C0199850
diagnosis of ductal carcinoma in situ (dcis) or carcinoma in the breast to be studied (opposite breast may also be studied)
Beschreibung

diagnosis of ductal carcinoma in situ (dcis)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0007124
hormone receptor status not specified
Beschreibung

hormone receptor status not specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0205370
patient characteristics:
Beschreibung

patient characteristics:

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
female
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
pre- or post-menopausal
Beschreibung

pre- or post-menopausal

Datentyp

boolean

Alias
UMLS CUI [1]
C0279752
not currently pregnant or pregnant within the past 12 months
Beschreibung

Gravidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0600457
must not have lactated within the past 12 months
Beschreibung

Not lactating

Datentyp

boolean

Alias
UMLS CUI [1]
C2826207
no active infection or inflammation in the breast to be studied
Beschreibung

Mastitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0024894
no known allergy to lidocaine, prilocaine, or marcaine (bupivacaine)
Beschreibung

Drug allergies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0023660
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0033124
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2945665
prior concurrent therapy:
Beschreibung

prior concurrent therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2114510
UMLS CUI [1,2]
C0009429
see disease characteristics
Beschreibung

disease characteristics

Datentyp

boolean

Alias
UMLS CUI [1]
C0599878
no prior subareolar surgery or other breast procedure that may disrupt the ductal system within 2 cm of the nipple in the breast to be studied
Beschreibung

subareolar surgery or other breast procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0473520
UMLS CUI [1,2]
C3714726
no prior breast implant that disrupts the ductal architecture in the breast to be studied
Beschreibung

breast implant

Datentyp

boolean

Alias
UMLS CUI [1]
C0179412
no prior silicone injections in the breast to be studied
Beschreibung

silicone injections in the breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021483
UMLS CUI [1,2]
C0006141
no prior radiotherapy to the breast to be studied
Beschreibung

radiotherapy to the breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0948310
no chemotherapy within the past 6 months
Beschreibung

chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C3665472
concurrent prophylactic chemotherapy allowed
Beschreibung

concurrent prophylactic chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0282515
UMLS CUI [1,2]
C0009429
no concurrent participation in another research study that may conflict with or affect the outcome of this study
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Breast Cancer NCT00896857

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
agrees to undergo breast surgical procedure
Item
agrees to undergo breast surgical procedure and meets one of the following criteria:
boolean
C2972960 (UMLS CUI [1,1])
C3714726 (UMLS CUI [1,2])
scheduled to undergo breast biopsy based on suspicious mammographic or clinical breast examination findings
Item
scheduled to undergo breast biopsy based on suspicious mammographic or clinical breast examination findings
boolean
C0405352 (UMLS CUI [1])
C1742735 (UMLS CUI [2])
C0199850 (UMLS CUI [3])
diagnosis of ductal carcinoma in situ (dcis)
Item
diagnosis of ductal carcinoma in situ (dcis) or carcinoma in the breast to be studied (opposite breast may also be studied)
boolean
C0011900 (UMLS CUI [1,1])
C0007124 (UMLS CUI [1,2])
hormone receptor status not specified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
patient characteristics:
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
pre- or post-menopausal
Item
pre- or post-menopausal
boolean
C0279752 (UMLS CUI [1])
Gravidity
Item
not currently pregnant or pregnant within the past 12 months
boolean
C0600457 (UMLS CUI [1])
Not lactating
Item
must not have lactated within the past 12 months
boolean
C2826207 (UMLS CUI [1])
Mastitis
Item
no active infection or inflammation in the breast to be studied
boolean
C0024894 (UMLS CUI [1])
Drug allergies
Item
no known allergy to lidocaine, prilocaine, or marcaine (bupivacaine)
boolean
C0020517 (UMLS CUI [1,1])
C0023660 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0033124 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2945665 (UMLS CUI [3,2])
prior concurrent therapy
Item
prior concurrent therapy:
boolean
C2114510 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
disease characteristics
Item
see disease characteristics
boolean
C0599878 (UMLS CUI [1])
subareolar surgery or other breast procedure
Item
no prior subareolar surgery or other breast procedure that may disrupt the ductal system within 2 cm of the nipple in the breast to be studied
boolean
C0473520 (UMLS CUI [1,1])
C3714726 (UMLS CUI [1,2])
breast implant
Item
no prior breast implant that disrupts the ductal architecture in the breast to be studied
boolean
C0179412 (UMLS CUI [1])
silicone injections in the breast
Item
no prior silicone injections in the breast to be studied
boolean
C0021483 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
radiotherapy to the breast
Item
no prior radiotherapy to the breast to be studied
boolean
C0948310 (UMLS CUI [1])
chemotherapy
Item
no chemotherapy within the past 6 months
boolean
C3665472 (UMLS CUI [1])
concurrent prophylactic chemotherapy
Item
concurrent prophylactic chemotherapy allowed
boolean
C0282515 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
Study Subject Participation Status
Item
no concurrent participation in another research study that may conflict with or affect the outcome of this study
boolean
C2348568 (UMLS CUI [1])
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