ID

26973

Beschreibung

MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00978770

Link

https://clinicaltrials.gov/show/NCT00978770

Stichworte

Versionen (1)
  1. 29.10.17 29.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Oktober 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00978770

Englisch

Eligibility Breast Cancer NCT00978770

1 Formulare  
Criteria
Beschreibung

Criteria

newly diagnosed, histologically proven breast cancer
Beschreibung

Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
stage t2-4b, n0-3c, and m0 disease
Beschreibung

Disease TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
locally advanced primary disease
Beschreibung

Primary disorder Advanced Local

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277554
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
underwent both x-ray mammography and breast ultrasound scanning during the current treatment episode
Beschreibung

Mammography | Ultrasonography, Mammary

Datentyp

boolean

Alias
UMLS CUI [1]
C0024671
UMLS CUI [2]
C0080264
scheduled for neoadjuvant chemotherapy
Beschreibung

Chemotherapy Neoadjuvant Scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0205539
patient characteristics:
Beschreibung

Client Characteristics

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
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
medically stable
Beschreibung

Stable status Medical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205476
no renal failure
Beschreibung

Exclusion | Kidney Failure

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0035078
no serious breast trauma within the past 3 months
Beschreibung

Exclusion | BREAST INJURY TRAUMA Serious

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0741715
UMLS CUI [2,2]
C0205404
no known allergic reaction associated with previous administration of a paramagnetic contrast agent
Beschreibung

Exclusion | Allergic Reaction Paramagnetic Contrast Agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C2917410
no known contraindication to magnetic resonance (mr) scanning
Beschreibung

Exclusion | Medical contraindication Magnetic Resonance Imaging

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0024485
must pass the normal safety requirements of mr, particularly pacemakers and cardiac defibrillators
Beschreibung

Safety Requirement Magnetic Resonance Imaging | Safety Requirement Artificial cardiac pacemaker | Safety Requirement Cardiac defibrillator

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036043
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C0036043
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0030163
UMLS CUI [3,1]
C0036043
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C1391956
no disability preventing mr scanning in the prone position
Beschreibung

Exclusion | Disability Preventing Magnetic Resonance Imaging Prone Position

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0231170
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0024485
UMLS CUI [2,4]
C0033422
no body habitus incompatible with mr system entry
Beschreibung

Exclusion | Body habitus Inappropriate Magnetic resonance imaging unit

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C1318474
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0336660
prior concurrent therapy:
Beschreibung

Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beschreibung

ID.17

Datentyp

boolean

no prior chemotherapy
Beschreibung

Exclusion | Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0392920
no prior surgery or radiotherapy for cancer in the ipsilateral breast
Beschreibung

Exclusion Criteria | Operative Surgical Procedures Breast Carcinoma Ipsilateral | Therapeutic radiology procedure Breast Carcinoma Ipsilateral

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0441989
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0678222
UMLS CUI [3,3]
C0441989
more than 4 months since prior surgery to the ipsilateral breast for benign breast disease
Beschreibung

Operative Surgical Procedures Breast Ipsilateral | Breast Disease Benign

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0441989
UMLS CUI [2,1]
C0006145
UMLS CUI [2,2]
C0205183
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Ähnliche Modelle

Eligibility Breast Cancer NCT00978770

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Breast Carcinoma
Item
newly diagnosed, histologically proven breast cancer
boolean
C0678222 (UMLS CUI [1])
Disease TNM Breast tumor staging
Item
stage t2-4b, n0-3c, and m0 disease
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Primary disorder Advanced Local
Item
locally advanced primary disease
boolean
C0277554 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Mammography | Ultrasonography, Mammary
Item
underwent both x-ray mammography and breast ultrasound scanning during the current treatment episode
boolean
C0024671 (UMLS CUI [1])
C0080264 (UMLS CUI [2])
Chemotherapy Neoadjuvant Scheduled
Item
scheduled for neoadjuvant chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Exclusion Criteria | Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0680251 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Stable status Medical
Item
medically stable
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
Exclusion | Kidney Failure
Item
no renal failure
boolean
C2828389 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
Exclusion | BREAST INJURY TRAUMA Serious
Item
no serious breast trauma within the past 3 months
boolean
C2828389 (UMLS CUI [1])
C0741715 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Exclusion | Allergic Reaction Paramagnetic Contrast Agent
Item
no known allergic reaction associated with previous administration of a paramagnetic contrast agent
boolean
C2828389 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C2917410 (UMLS CUI [2,2])
Exclusion | Medical contraindication Magnetic Resonance Imaging
Item
no known contraindication to magnetic resonance (mr) scanning
boolean
C2828389 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Safety Requirement Magnetic Resonance Imaging | Safety Requirement Artificial cardiac pacemaker | Safety Requirement Cardiac defibrillator
Item
must pass the normal safety requirements of mr, particularly pacemakers and cardiac defibrillators
boolean
C0036043 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0036043 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0030163 (UMLS CUI [2,3])
C0036043 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C1391956 (UMLS CUI [3,3])
Exclusion | Disability Preventing Magnetic Resonance Imaging Prone Position
Item
no disability preventing mr scanning in the prone position
boolean
C2828389 (UMLS CUI [1])
C0231170 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0033422 (UMLS CUI [2,4])
Exclusion | Body habitus Inappropriate Magnetic resonance imaging unit
Item
no body habitus incompatible with mr system entry
boolean
C2828389 (UMLS CUI [1])
C1318474 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0336660 (UMLS CUI [2,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.17
Item
see disease characteristics
boolean
Exclusion | Chemotherapy
Item
no prior chemotherapy
boolean
C2828389 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Exclusion Criteria | Operative Surgical Procedures Breast Carcinoma Ipsilateral | Therapeutic radiology procedure Breast Carcinoma Ipsilateral
Item
no prior surgery or radiotherapy for cancer in the ipsilateral breast
boolean
C0680251 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0441989 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0441989 (UMLS CUI [3,3])
Operative Surgical Procedures Breast Ipsilateral | Breast Disease Benign
Item
more than 4 months since prior surgery to the ipsilateral breast for benign breast disease
boolean
C0543467 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0006145 (UMLS CUI [2,1])
C0205183 (UMLS CUI [2,2])
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