ID

16424

Beschrijving

Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01215162

Link

https://clinicaltrials.gov/show/NCT01215162

Trefwoorden

Versies (1)
  1. 15-07-16 15-07-16 -
Geüploaded op

15 juli 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT01215162

Engels

Eligibility Breast Cancer NCT01215162

1 Formulieren  
Criteria
Beschrijving

Criteria

1. histologically proven primary invasive breast carcinoma.
Beschrijving

Invasive carcinoma of breast Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205225
2. tumor pathologically determined <= 5cm in diameter.
Beschrijving

Tumor size Diameter

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1301886
3. single, discrete, well-defined primary tumor.
Beschrijving

primary tumor Well defined Discrete Single

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0442825
UMLS CUI [1,3]
C0443299
UMLS CUI [1,4]
C0205171
4. any micro-calcifications must be focal. a specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications.
Beschrijving

Microcalcification Focal | Specimen Radiographic | Lumpectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0521174
UMLS CUI [1,2]
C0205234
UMLS CUI [2,1]
C0370003
UMLS CUI [2,2]
C0444708
UMLS CUI [3]
C0740370
5. pathologically negative surgical margins.
Beschrijving

Negative Surgical Margin

Datatype

boolean

Alias
UMLS CUI [1]
C1709157
6. axillary lymph node status can be determined by level i and ii lymph node dissection or sentinel lymph node sampling.
Beschrijving

Axillary lymph node Status | Excision of axillary lymph nodes | Sentinel Lymph Node Sampling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C0449438
UMLS CUI [2]
C0193867
UMLS CUI [3,1]
C1522495
UMLS CUI [3,2]
C0441621
7. ecog performance status 0-2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
contraindications:
Beschrijving

Medical contraindication

Datatype

boolean

Alias
UMLS CUI [1]
C1301624
1. multicentric disease and/or diffuse malignant appearing microcalcifications.
Beschrijving

Disease Multicentric | Microcalcification Malignant Diffuse

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439743
UMLS CUI [2,1]
C0521174
UMLS CUI [2,2]
C0205282
UMLS CUI [2,3]
C0205219
2. evidence of metastatic breast cancer.
Beschrijving

Carcinoma breast stage IV Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0278488
UMLS CUI [1,2]
C0332120
3. axillary lymph node involvement.
Beschrijving

Axillary Lymph Node Involvement

Datatype

boolean

Alias
UMLS CUI [1]
C0741343
4. pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy.
Beschrijving

Collagen-vascular disease Pre-existing | Rheumatoid Arthritis Requirement Therapeutic immunosuppression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262428
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021079
5. prior irradiation to the ara of planned radiation field.
Beschrijving

prior radiation therapy Area | Radiation Field Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205146
UMLS CUI [2,1]
C1882536
UMLS CUI [2,2]
C1301732
6. pregnant or lactating women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT01215162

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Invasive carcinoma of breast Primary
Item
1. histologically proven primary invasive breast carcinoma.
boolean
C0853879 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Tumor size Diameter
Item
2. tumor pathologically determined <= 5cm in diameter.
boolean
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
primary tumor Well defined Discrete Single
Item
3. single, discrete, well-defined primary tumor.
boolean
C0677930 (UMLS CUI [1,1])
C0442825 (UMLS CUI [1,2])
C0443299 (UMLS CUI [1,3])
C0205171 (UMLS CUI [1,4])
Microcalcification Focal | Specimen Radiographic | Lumpectomy
Item
4. any micro-calcifications must be focal. a specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications.
boolean
C0521174 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0370003 (UMLS CUI [2,1])
C0444708 (UMLS CUI [2,2])
C0740370 (UMLS CUI [3])
Negative Surgical Margin
Item
5. pathologically negative surgical margins.
boolean
C1709157 (UMLS CUI [1])
Axillary lymph node Status | Excision of axillary lymph nodes | Sentinel Lymph Node Sampling
Item
6. axillary lymph node status can be determined by level i and ii lymph node dissection or sentinel lymph node sampling.
boolean
C0729594 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0193867 (UMLS CUI [2])
C1522495 (UMLS CUI [3,1])
C0441621 (UMLS CUI [3,2])
ECOG performance status
Item
7. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Medical contraindication
Item
contraindications:
boolean
C1301624 (UMLS CUI [1])
Disease Multicentric | Microcalcification Malignant Diffuse
Item
1. multicentric disease and/or diffuse malignant appearing microcalcifications.
boolean
C0012634 (UMLS CUI [1,1])
C0439743 (UMLS CUI [1,2])
C0521174 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
C0205219 (UMLS CUI [2,3])
Carcinoma breast stage IV Evidence of
Item
2. evidence of metastatic breast cancer.
boolean
C0278488 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Axillary Lymph Node Involvement
Item
3. axillary lymph node involvement.
boolean
C0741343 (UMLS CUI [1])
Collagen-vascular disease Pre-existing | Rheumatoid Arthritis Requirement Therapeutic immunosuppression
Item
4. pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy.
boolean
C0262428 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021079 (UMLS CUI [2,3])
prior radiation therapy Area | Radiation Field Planned
Item
5. prior irradiation to the ara of planned radiation field.
boolean
C0279134 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1882536 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
6. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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