ID

12983

Beschrijving

Randomized Trial on Intraoperative Radiotherapy Full Dose Vs External Radiotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01849133

Link

https://clinicaltrials.gov/show/NCT01849133

Trefwoorden

  1. 09-01-16 09-01-16 -
Geüploaded op

9 januari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Carcinoma Breast NCT01849133

Eligibility Carcinoma Breast NCT01849133

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 48 and < 75
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
clinical mammographic/ultrasound diagnosis of unicentric carcinoma, with ultrasound diameter ≤2.5 cm. advisable, but not mandatory, the execution of mammoscintigraphy with mdp-99mtc (methyl diphosphonate technetium-99m) : this procedure allows the bone staging and the mapping of eventual multi-focality/multi-centricity of the breast neoplasm.
Beschrijving

diagnostics

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0080264
UMLS CUI [3]
C0034606
UMLS CUI [4]
C0024671
no previous therapy (biopsy included) for breast cancer in other institutions.
Beschrijving

therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
patients with non-palpable lesions will undergo preoperative centering and stereotactic and/or ultrasound-guided cytology (the execution of this last procedure is not mandatory).
Beschrijving

palpation

Datatype

boolean

Alias
UMLS CUI [1]
C0010819
UMLS CUI [2]
C0030247
adequate information to the patient and informed consent.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
ductal or lobular non-infiltrating carcinoma.
Beschrijving

breast carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
paget disease.
Beschrijving

paget disease

Datatype

boolean

Alias
UMLS CUI [1]
C1704323
tumor in close proximity to the skin.
Beschrijving

skin

Datatype

boolean

Alias
UMLS CUI [1]
C1123023
tumor in the axillary tail.
Beschrijving

axillary tail

Datatype

boolean

Alias
UMLS CUI [1]
C0559063
documented multi-centricity/multi-focality of the tumor.
Beschrijving

multicentric breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C2986664
patients who underwent excisional biopsy in other institutions.
Beschrijving

biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0005558
histology different from carcinoma.
Beschrijving

histology

Datatype

boolean

Alias
UMLS CUI [1]
C0019638
personal anamnesis positive for malignancy (basocellular carcinoma, in situ carcinoma of the cervix, contralateral breast cancer free of disease after 15 years of follow-up excluded).
Beschrijving

malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
general contraindications to regular follow-up or radiotherapy.
Beschrijving

contraindication

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1522449

Similar models

Eligibility Carcinoma Breast NCT01849133

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age ≥ 48 and < 75
boolean
C0001779 (UMLS CUI [1])
diagnostics
Item
clinical mammographic/ultrasound diagnosis of unicentric carcinoma, with ultrasound diameter ≤2.5 cm. advisable, but not mandatory, the execution of mammoscintigraphy with mdp-99mtc (methyl diphosphonate technetium-99m) : this procedure allows the bone staging and the mapping of eventual multi-focality/multi-centricity of the breast neoplasm.
boolean
C0678222 (UMLS CUI [1])
C0080264 (UMLS CUI [2])
C0034606 (UMLS CUI [3])
C0024671 (UMLS CUI [4])
therapy
Item
no previous therapy (biopsy included) for breast cancer in other institutions.
boolean
C0087111 (UMLS CUI [1])
palpation
Item
patients with non-palpable lesions will undergo preoperative centering and stereotactic and/or ultrasound-guided cytology (the execution of this last procedure is not mandatory).
boolean
C0010819 (UMLS CUI [1])
C0030247 (UMLS CUI [2])
informed consent
Item
adequate information to the patient and informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
breast carcinoma
Item
ductal or lobular non-infiltrating carcinoma.
boolean
C0678222 (UMLS CUI [1])
paget disease
Item
paget disease.
boolean
C1704323 (UMLS CUI [1])
skin
Item
tumor in close proximity to the skin.
boolean
C1123023 (UMLS CUI [1])
axillary tail
Item
tumor in the axillary tail.
boolean
C0559063 (UMLS CUI [1])
multicentric breast cancer
Item
documented multi-centricity/multi-focality of the tumor.
boolean
C2986664 (UMLS CUI [1])
biopsy
Item
patients who underwent excisional biopsy in other institutions.
boolean
C0005558 (UMLS CUI [1])
histology
Item
histology different from carcinoma.
boolean
C0019638 (UMLS CUI [1])
malignancy
Item
personal anamnesis positive for malignancy (basocellular carcinoma, in situ carcinoma of the cervix, contralateral breast cancer free of disease after 15 years of follow-up excluded).
boolean
C0006826 (UMLS CUI [1])
contraindication
Item
general contraindications to regular follow-up or radiotherapy.
boolean
C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])

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