ID

20193

Beschrijving

Radiation Therapy in Treating Women With Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00814567

Link

https://clinicaltrials.gov/show/NCT00814567

Trefwoorden

  1. 11-02-17 11-02-17 -
Geüploaded op

11 februari 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00814567

Eligibility Breast Cancer NCT00814567

Criteria
Beschrijving

Criteria

Alias
UMLS CUI-1
C0242801
diagnosis of low-risk early stage breast cancer, meeting the following criteria:
Beschrijving

Low-risk early stage breast cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986665
UMLS CUI [1,2]
C3538919
invasive adenocarcinoma
Beschrijving

Invasive adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
no invasive carcinoma of classical lobular type
Beschrijving

Invasive Lobular Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0279565
no lymphovascular invasion
Beschrijving

Lymphovascular invasion

Datatype

boolean

Alias
UMLS CUI [1]
C1708790
tumor size pathologically determined to be ≤ 3.0 cm in diameter (pt1-2) (< 3.1 cm maximum microscopic diameter of invasive component)
Beschrijving

Tumor size

Datatype

boolean

Alias
UMLS CUI [1]
C0475440
unifocal disease
Beschrijving

Unifocal disease

Datatype

boolean

Alias
UMLS CUI [1]
C1710542
grade i, ii, or iii disease
Beschrijving

Grading

Datatype

boolean

Alias
UMLS CUI [1]
C0919553
axillary lymph nodes negative (pn0)
Beschrijving

Axillary lymph nodes

Datatype

boolean

Alias
UMLS CUI [1]
C0729594
sentinel lymph node biopsy and isolated tumor cells < 0.2 mm allowed
Beschrijving

Sentinel lymph node

Datatype

boolean

Alias
UMLS CUI [1]
C0796693
must have undergone breast conservation surgery with or without adjuvant systemic therapy
Beschrijving

Breast-Conserving Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0917927
minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia)
Beschrijving

Tumor margin status

Datatype

boolean

Alias
UMLS CUI [1]
C1269830
at low risk of local recurrence after radiotherapy (< 1% annual risk local recurrence)
Beschrijving

Recurrence Risk

Datatype

boolean

Alias
UMLS CUI [1]
C2986492
no prior mastectomy
Beschrijving

Mastectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0024881
no blood-borne metastases
Beschrijving

Hematogen metastases

Datatype

boolean

Alias
UMLS CUI [1,1]
C1700301
UMLS CUI [1,2]
C0027627
patient characteristics:
Beschrijving

Patient characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
no prior malignancy except nonmelanoma skin cancer
Beschrijving

Prior malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C2735088
prior concurrent therapy:
Beschrijving

Concurrent therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0009429
see disease characteristics
Beschrijving

Disease characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C1705348
no prior endocrine therapy or chemotherapy
Beschrijving

Endocrine therapy or chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0392920
neoadjuvant endocrine therapy allowed provided the tumour is < 3.0 cm and all other inclusion criteria are met
Beschrijving

Neoadjuvant endocrine therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0279025
no primary endocrine therapy as a replacement for surgery
Beschrijving

Primary endocrine therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0279025
no concurrent chemoradiotherapy
Beschrijving

Concurrent chemoradiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C3178775

Similar models

Eligibility Breast Cancer NCT00814567

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Criteria
C0242801 (UMLS CUI-1)
Low-risk early stage breast cancer
Item
diagnosis of low-risk early stage breast cancer, meeting the following criteria:
boolean
C2986665 (UMLS CUI [1,1])
C3538919 (UMLS CUI [1,2])
Invasive adenocarcinoma
Item
invasive adenocarcinoma
boolean
C0853879 (UMLS CUI [1])
Invasive Lobular Breast Carcinoma
Item
no invasive carcinoma of classical lobular type
boolean
C0279565 (UMLS CUI [1])
Lymphovascular invasion
Item
no lymphovascular invasion
boolean
C1708790 (UMLS CUI [1])
Tumor size
Item
tumor size pathologically determined to be ≤ 3.0 cm in diameter (pt1-2) (< 3.1 cm maximum microscopic diameter of invasive component)
boolean
C0475440 (UMLS CUI [1])
Unifocal disease
Item
unifocal disease
boolean
C1710542 (UMLS CUI [1])
Grading
Item
grade i, ii, or iii disease
boolean
C0919553 (UMLS CUI [1])
Axillary lymph nodes
Item
axillary lymph nodes negative (pn0)
boolean
C0729594 (UMLS CUI [1])
Sentinel lymph node
Item
sentinel lymph node biopsy and isolated tumor cells < 0.2 mm allowed
boolean
C0796693 (UMLS CUI [1])
Breast-Conserving Surgery
Item
must have undergone breast conservation surgery with or without adjuvant systemic therapy
boolean
C0917927 (UMLS CUI [1])
Tumor margin status
Item
minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia)
boolean
C1269830 (UMLS CUI [1])
Recurrence Risk
Item
at low risk of local recurrence after radiotherapy (< 1% annual risk local recurrence)
boolean
C2986492 (UMLS CUI [1])
Mastectomy
Item
no prior mastectomy
boolean
C0024881 (UMLS CUI [1])
Hematogen metastases
Item
no blood-borne metastases
boolean
C1700301 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Patient characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Prior malignancy
Item
no prior malignancy except nonmelanoma skin cancer
boolean
C2735088 (UMLS CUI [1])
Concurrent therapy
Item
prior concurrent therapy:
boolean
C0009429 (UMLS CUI [1])
Disease characteristics
Item
see disease characteristics
boolean
C1705348 (UMLS CUI [1])
Endocrine therapy or chemotherapy
Item
no prior endocrine therapy or chemotherapy
boolean
C0279025 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Neoadjuvant endocrine therapy
Item
neoadjuvant endocrine therapy allowed provided the tumour is < 3.0 cm and all other inclusion criteria are met
boolean
C0600558 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
Primary endocrine therapy
Item
no primary endocrine therapy as a replacement for surgery
boolean
C1708063 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
Concurrent chemoradiotherapy
Item
no concurrent chemoradiotherapy
boolean
C3178775 (UMLS CUI [1])

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