ID

17358

Beschreibung

Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00694577

Link

https://clinicaltrials.gov/show/NCT00694577

Stichworte

Versionen (1)
  1. 08.09.16 08.09.16 -
Hochgeladen am

8. September 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Ductal Breast Cancer NCT00694577

Englisch

Eligibility Ductal Breast Cancer NCT00694577

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed unicentric stage i invasive ductal breast cancer. histologically negative tumor margin 2mm or more from any inked edges, or no tumor in re-excision specimen or final shaved specimen.
Beschreibung

Invasive Ductal Breast Carcinoma Center One | TNM clinical staging | Tumor margin status | Reexcision Specimen | Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1134719
UMLS CUI [1,2]
C0205099
UMLS CUI [1,3]
C0205447
UMLS CUI [2]
C3258246
UMLS CUI [3]
C1269830
UMLS CUI [4,1]
C0184913
UMLS CUI [4,2]
C0370003
UMLS CUI [5]
C0006826
patient may have been treated with adjuvant chemotherapy, or be on adjuvant hormonal therapy or begin hormonal therapy following xrt
Beschreibung

Chemotherapy, Adjuvant | adjuvant hormonal therapy | Hormone Therapy | X-ray beam therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2]
C2367461
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0436209
18 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
required laboratory data as outlined in the protocol
Beschreibung

Laboratory Results Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
multicentric idc of the breast defined as discontiguous tumors separated by at least 5cm of uninvolved tissue
Beschreibung

Invasive Ductal Breast Carcinoma Multicentric | Malignant Neoplasms Separated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1134719
UMLS CUI [1,2]
C0439743
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0443299
multifocal idc of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region
Beschreibung

Invasive Ductal Breast Carcinoma Multifocal | Invasive Carcinoma Foci Discrete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1134719
UMLS CUI [1,2]
C0205292
UMLS CUI [2,1]
C1334274
UMLS CUI [2,2]
C0205234
UMLS CUI [2,3]
C0443299
tumor > 2.0cm, nodal involvement, or metastatic involvement
Beschreibung

Tumor size | Lymph Node Involvement | Involvement Metastatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2]
C0806692
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0036525
histological evidence of: lymphovascular invasion; blood vessel invasion; extensive intraductal component; invasive lobular carcinoma and infiltrating carcinoma of mixed ductal and lobular type; dcis with microinvasion and dcis suspicious for microinvasion; infiltrating micropapillary carcinoma
Beschreibung

Lymphatic Invasion | Blood Vessel Invasion | Prominent Intraductal Component Present | Invasive Lobular Breast Carcinoma | Infiltrating duct and lobular carcinoma | Ductal Carcinoma In Situ with Microinvasion | Invasive micropapillary carcinoma of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C1708790
UMLS CUI [2,1]
C0005847
UMLS CUI [2,2]
C1269955
UMLS CUI [3]
C1882485
UMLS CUI [4]
C0279565
UMLS CUI [5]
C0334384
UMLS CUI [6]
C2732473
UMLS CUI [7]
C3838947
known mutation carrier, including brca1 and brca2
Beschreibung

Mutation Carrier | BRCA1 gene | BRCA2 gene

Datentyp

boolean

Alias
UMLS CUI [1]
C2985478
UMLS CUI [2]
C0376571
UMLS CUI [3]
C0598034
history of cosmetic or reconstructive breast surgery
Beschreibung

Breast cosmetic surgery | surgery; reconstructive, breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0549358
UMLS CUI [2]
C1408823
psychiatric illness which would prevent the patient from giving informed consent
Beschreibung

Mental disorders Preventing Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or connective tissue disease
Beschreibung

Communicable Disease Uncontrolled | Diabetic - poor control | Connective Tissue Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0421258
UMLS CUI [3,1]
C0009782
UMLS CUI [3,2]
C0205318
participants with a "currently active" second malignancy other than non-melanoma skin cancers
Beschreibung

Neoplasms, Second Primary | Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2]
C0699893
patients with diffuse (> 1 quadrant or >5cm) suspicious microcalcifications
Beschreibung

Diffuse microcalcifications of breast Breast quadrant Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2919226
UMLS CUI [1,2]
C0447660
UMLS CUI [1,3]
C1265611
women who are pregnant
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
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Ähnliche Modelle

Eligibility Ductal Breast Cancer NCT00694577

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive Ductal Breast Carcinoma Center One | TNM clinical staging | Tumor margin status | Reexcision Specimen | Malignant Neoplasms
Item
histologically confirmed unicentric stage i invasive ductal breast cancer. histologically negative tumor margin 2mm or more from any inked edges, or no tumor in re-excision specimen or final shaved specimen.
boolean
C1134719 (UMLS CUI [1,1])
C0205099 (UMLS CUI [1,2])
C0205447 (UMLS CUI [1,3])
C3258246 (UMLS CUI [2])
C1269830 (UMLS CUI [3])
C0184913 (UMLS CUI [4,1])
C0370003 (UMLS CUI [4,2])
C0006826 (UMLS CUI [5])
Chemotherapy, Adjuvant | adjuvant hormonal therapy | Hormone Therapy | X-ray beam therapy
Item
patient may have been treated with adjuvant chemotherapy, or be on adjuvant hormonal therapy or begin hormonal therapy following xrt
boolean
C0085533 (UMLS CUI [1])
C2367461 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0436209 (UMLS CUI [4])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Study Protocol
Item
required laboratory data as outlined in the protocol
boolean
C1254595 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Invasive Ductal Breast Carcinoma Multicentric | Malignant Neoplasms Separated
Item
multicentric idc of the breast defined as discontiguous tumors separated by at least 5cm of uninvolved tissue
boolean
C1134719 (UMLS CUI [1,1])
C0439743 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0443299 (UMLS CUI [2,2])
Invasive Ductal Breast Carcinoma Multifocal | Invasive Carcinoma Foci Discrete
Item
multifocal idc of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region
boolean
C1134719 (UMLS CUI [1,1])
C0205292 (UMLS CUI [1,2])
C1334274 (UMLS CUI [2,1])
C0205234 (UMLS CUI [2,2])
C0443299 (UMLS CUI [2,3])
Tumor size | Lymph Node Involvement | Involvement Metastatic
Item
tumor > 2.0cm, nodal involvement, or metastatic involvement
boolean
C0475440 (UMLS CUI [1])
C0806692 (UMLS CUI [2])
C1314939 (UMLS CUI [3,1])
C0036525 (UMLS CUI [3,2])
Lymphatic Invasion | Blood Vessel Invasion | Prominent Intraductal Component Present | Invasive Lobular Breast Carcinoma | Infiltrating duct and lobular carcinoma | Ductal Carcinoma In Situ with Microinvasion | Invasive micropapillary carcinoma of breast
Item
histological evidence of: lymphovascular invasion; blood vessel invasion; extensive intraductal component; invasive lobular carcinoma and infiltrating carcinoma of mixed ductal and lobular type; dcis with microinvasion and dcis suspicious for microinvasion; infiltrating micropapillary carcinoma
boolean
C1708790 (UMLS CUI [1])
C0005847 (UMLS CUI [2,1])
C1269955 (UMLS CUI [2,2])
C1882485 (UMLS CUI [3])
C0279565 (UMLS CUI [4])
C0334384 (UMLS CUI [5])
C2732473 (UMLS CUI [6])
C3838947 (UMLS CUI [7])
Mutation Carrier | BRCA1 gene | BRCA2 gene
Item
known mutation carrier, including brca1 and brca2
boolean
C2985478 (UMLS CUI [1])
C0376571 (UMLS CUI [2])
C0598034 (UMLS CUI [3])
Breast cosmetic surgery | surgery; reconstructive, breast
Item
history of cosmetic or reconstructive breast surgery
boolean
C0549358 (UMLS CUI [1])
C1408823 (UMLS CUI [2])
Mental disorders Preventing Informed Consent
Item
psychiatric illness which would prevent the patient from giving informed consent
boolean
C0004936 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Communicable Disease Uncontrolled | Diabetic - poor control | Connective Tissue Disease Uncontrolled
Item
medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or connective tissue disease
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0421258 (UMLS CUI [2])
C0009782 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Neoplasms, Second Primary | Skin carcinoma
Item
participants with a "currently active" second malignancy other than non-melanoma skin cancers
boolean
C0085183 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Diffuse microcalcifications of breast Breast quadrant Quantity
Item
patients with diffuse (> 1 quadrant or >5cm) suspicious microcalcifications
boolean
C2919226 (UMLS CUI [1,1])
C0447660 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Pregnancy
Item
women who are pregnant
boolean
C0032961 (UMLS CUI [1])
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